Salix Pharmaceuticals Reports 4Q2009 And FY2009 Results
30% Increase in Year–over–Year Product Revenue
XIFAXAN® 550 mg for Hepatic Encephalopathy
NDA Submitted
FDA Action Date March 24, 2010
FDA Gastrointestinal Drugs Advisory Committee Recommends Approval
XIFAXAN® 550 mg for Non–Constipation Irritable Bowel Syndrome
Two Phase 3 Trials Demonstrate Statistical Significance
Successful December 2009 Pre–NDA Meeting with GI Division
NDA Submission Targeted for June 2010
APRISO™ and METOZOLV™ ODT Launched
Rifaximin Intellectual Property Position Strengthened
RALEIGH, NC, March 09, 2010 – Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced
financial and operating results for the fourth quarter and
full year ended December 31, 2009.
Total product revenue was $70.2 million for the fourth quarter of 2009, a 16 percent increase compared to $60.6 million for the fourth quarter of 2008.
Total product revenue for full year 2009 was $232.9 million compared to $178.8 million for the full year 2008, a year–over–year increase
of 30 percent. XIFAXAN® revenue for the fourth quarter of 2009 was $24.9 million compared to $23.8 million for the fourth quarter
of 2008. XIFAXAN revenue increased 48 percent year–over–year, with full year 2009 revenue of $117.9 million compared to full year 2008
revenue of $79.9 million. Our key bowel cleansing products MOVIPREP® and OSMOPREP® generated combined revenue of $30.4
million for the fourth quarter of 2009, compared to $19.8 million for the fourth quarter of 2008 – a year–over–year increase of
54 percent. Total combined product revenue for these two products was $78.1 million for the full year 2009 and $64.2 million for the full year 2008
– a year–over–year increase of 22 percent.
Total cost of products sold was $17.5 million for the fourth quarter and $52.0 million for the full year 2009. Gross margin on total product revenue was
75.1% for the fourth quarter of 2009 compared to 75.9% for the fourth quarter of 2008; and 77.7% for the full year 2009, compared to 79.5% the full
year 2008. The lower gross margins for 2009 relative to the comparable periods for 2008 were primarily due to a change in the product revenue mix.
Research and development expenses were $19.9 million for the fourth quarter of 2009 and $89.5 million for the full year 2009, compared to $26.4 million and $83.7 million, respectively, for the prior year periods. Selling, general and administrative expenses were $36.4 million for the fourth quarter
of 2009 and $120.0 million for the full year 2009, compared to $27.5 million for the fourth quarter of 2008 and $95.1 million for the full year
2008. The Company reported a net loss of $7.0 million, or $0.13 per share, fully diluted, for the fourth quarter of 2009. The net loss for the full year was $43.6 million, or $0.88 per share, fully diluted. The loss of $0.88 per share for the year is in line with previously stated guidance of
a loss of approximately $0.90 per share.
In December 2009 the Company raised $128.4 million by means of an offering of common stock. This funding should facilitate our ability to more effectively
pursue strategic objectives. Cash and cash equivalents were $192.5 million on December 31, 2009.
Commenting on the performance of the Company, Adam Derbyshire, Executive Vice President and Chief Financial Officer, stated, "We continue to be pleased
with the Company's ongoing product revenue growth. Significant increases in revenue for both XIFAXAN and our bowel cleansers resulted in a 30 percent
year–over–year increase in total product revenue for 2009, in line with previously stated revenue guidance. We believe several factors
should contribute to an increase in product revenue over the coming years, namely the continued growth of our currently marketed products –
including APRISO™ and METOZOLV™ ODT, our two products launched in 2009; the launch of new product candidates currently
in late–stage development; the expanded contribution of rifaximin if additional indications are approved and the further expansion of our
product portfolio via development activities, licensing and acquisitions.
"We believe 2010 total Company product revenue, assuming a timely approval of XIFAXAN 550 mg for hepatic encephalopathy, will be approximately $334 million,
and that we will be able to generate approximately $0.04 in earnings per share, fully diluted, for the full year ending December 31, 2010. This
2010 revenue guidance represents 43 percent growth over 2009 revenue. The current annualized run rates, based on dollarizing the latest prescription
data for XIFAXAN, our bowel cleansing product line, APRISO and our "other products" are approximately $125 million, $84 million, $19 million and
$35 million, respectively.
"Salix continues to be committed to building on its core business and leveraging its leadership position in gastroenterology to create the leading U.S.
specialty pharmaceutical company providing innovative products to healthcare professionals to prevent or treat gastrointestinal disorders. To that
end, during 2009 the Company invested 38 percent of revenue in research and development efforts, including the submission of our NDA for XIFAXAN 550
mg for hepatic encephalopathy, the completion of our Phase 3 trials of XIFAXAN 550 mg for irritable bowel syndrome and the initiation of late–stage
trials for crofelemer and budesonide foam. During 2010 we intend to continue our research and development efforts, specifically the submission
of NDAs for XIFAXAN 550 mg for irritable bowel syndrome and crofelemer for HIV–associated diarrhea and the ongoing development of budesonide
foam. We anticipate investment in these projects and other research and development activities should require approximately $100 million, or 30 percent of anticipated 2010 revenue. During 2009 selling, general and administrative expenses totaled 52 percent of revenue as the continuing growth of our business and broadening of our product portfolio necessitated the expansion of our sales effort with the addition of a 64–member sales force
to complement the ongoing efforts of our existing 96–member sales force. Selling, general and administrative expenses in 2010, including the launch of XIFAXAN 550 mg for hepatic encephalopathy, should be approximately $153 million, or 46 percent of anticipated 2010 revenue.
"Based on the full year 2010 guidance provided above, for the first quarter of 2010 we anticipate total Company product revenue should be approximately
$40 million and should generate a loss of approximately $0.50 per share, fully diluted. This first quarter 2010 guidance incorporates the impact of
the XIFAXAN 550 mg business on the XIFAXAN 200 mg business, if XIFAXAN 550 mg is approved in a timely manner."
Carolyn Logan, President and Chief Executive Officer, stated, "2009 was one of the most exciting and rewarding years in the Company's history to date as
we continued to achieve success in both the commercial and product development areas of our business. Prescription demand for XIFAXAN grew 18 percent
and 14 percent for the fourth quarter and full year 2009, respectively, compared to the corresponding periods of 2008. December was a record month
for XIFAXAN with 45,000 prescriptions written totaling 2.3 million tablets. XIFAXAN has generated 21 consecutive quarters of growth since its launch in 2004. Prescription demand for MOVIPREP and OSMOPREP, combined, grew 11 percent and 19 percent, respectively, for the fourth quarter and full
year 2009 compared to the corresponding periods of 2008
"During 2009 we expanded our commercial portfolio with the launch of APRISO in March and the launch of METOZOLV ODT in November. APRISO is the first and
only once–daily 5–ASA, or mesalamine, product to offer both once–a–day dosing for the indication of maintenance of remission
as well as being the only mesalamine product to combine delivery in the form of delayed and extended release for the successful management of ulcerative
colitis. The ulcerative colitis market is transitioning from a multi–dose per day market to a once–a–day market, and we believe APRISO, with its unique Intellicor™ delivery system, should compete very effectively in this changing ulcerative colitis market
in the years to come. We continue to believe peak year U.S. sales of APRISO should exceed $100 million. METOZOLV ODT is the first available treatment
for both diabetic gastroparesis and symptomatic documented GERD that offers the similar safety and efficacy of metoclopramide with the added convenience of an orally disintegrating tablet formulation. We believe METOZOLV ODT again demonstrates our commitment to provide innovative products as well as formulations to meet the unmet treatment needs of physicians and patients. We believe peak year U.S. sales of METOZOLV ODT should exceed $50
million.
"We expanded our commercial operations during 2009 as our current business continues to grow and as we prepare for additional growth by means of the introduction
of anticipated new products and indications. We now have two specialty sales forces, our 96–member Integra sales force and our 64–member
Futura sales force, and we believe our expanded sales capability should position the Company to take full advantage of the opportunities
being generated by our expanding product portfolio.
"The Company made significant advancements in its late–stage product development efforts during 2009. We achieved numerous milestones in the development
of XIFAXAN 550 mg for the treatment of both hepatic encephalopathy and irritable bowel syndrome. In June positive results of our Phase 3 study
of XIFAXAN 550 mg in the treatment of hepatic encephalopathy (HE) were presented at Digestive Disease Week. The data from this 299–patient,
multinational, randomized, double–blind, placebo–controlled trial demonstrated that XIFAXAN 550 mg significantly reduced the risk of
HE–related hospitalizations in patients with previous episodes of HE and showed a highly significant reduction in the risk of breakthrough HE
during the six–month study. We submitted the NDA for this indication to the FDA on June 24, 2009, and the FDA granted Priority Review for our
application. On February 23, 2010 the Gastrointestinal Drugs Advisory Committee of the FDA reviewed the NDA and recommended by a vote of 14 to 4 in favor of the approval of the NDA. The FDA has issued an action date of March 24, 2010 for the XIFAXAN 550 mg HE NDA, and we look forward with great
anticipation to the timely review of the NDA. There are reported to be approximately 200,000 patients in the United States with overt HE. If approved,
XIFAXAN 550 mg will be the first new option for the management of HE in over 30 years. XIFAXAN has been granted Orphan Drug designation in HE.
We believe this designation will provide seven years of marketing exclusivity in the United States if XIFAXAN 550 mg gains approval from the FDA for HE.
"On September 14 we announced the successful outcome of our two Phase 3 randomized, double–blind, placebo–controlled, 600–patient, multicenter
trials – TARGET 1 and TARGET 2 – designed to evaluate the efficacy and safety of XIFAXAN 550 mg tablets in the treatment of patients
with non–constipation irritable bowel syndrome (IBS). In each trial, XIFAXAN 550 mg–treated patients demonstrated a statistically
significant improvement for both the primary endpoint and key secondary endpoint compared to placebo–treated patients. XIFAXAN 550 mg delivered
adequate relief of IBS symptoms and relief of IBS–related bloating over a one–month period following the completion of a 14–day
course of therapy. The results of these two trials affirm the utility of a gut–selective antibiotic in the treatment of IBS. In December 2009 we held a pre–NDA meeting with the GI Division of the FDA to discuss the submission of our NDA based on the successful outcome of these two
trials. We continue to target a June 2010 submission of a New Drug Application seeking marketing approval for XIFAXAN 550 mg as a treatment for non–constipation
IBS.
"We also are pleased to report that Dr. Mark Pimentel, Lead Investigator for TARGET 1 and TARGET 2, has been selected to present the results of these trials
at a Plenary Session of Digestive Disease Week (DDW) 2010 on May 3, 2010. We anticipate a high level of interest regarding both our IBS and HE
Phase 3 results at the upcoming DDW meeting and look forward to the opportunity DDW should provide for scientific exchange regarding the results.
"As part of the Company's lifecycle management strategy for rifaximin, during 2009 we continued to broaden, strengthen and expand the intellectual property
portfolio related to this compound. Further strengthening our patent estate, two additional patents relating to rifaximin were issued by the U.S.
Patent and Trademark Office during 2009. One patent provides further protection relating to a previously–issued patent that covers several
physical states, or polymorphous forms, of rifaximin. This patent has been listed in the Orange Book and should provide protection until June 2024.
The other patent provides protection for rifaximin relating to treating bloating caused by small intestinal bacterial overgrowth associated with
irritable bowel syndrome. The patent should be listed in the Orange Book if and when marketing approval is granted to rifaximin for the treatment of IBS. The patent should provide protection until August 2019.
"During the year we secured the exclusive right in the United States to Lupin's bioadhesive drug delivery technology for use with rifaximin. In October
we secured the exclusive right in the United States to Cipla's amorphous rifaximin PCT Patent Application. The acquisition of the rights to Lupin's
and Cipla's proprietary rights should serve to further protect rifaximin's intellectual property position.
"The development of crofelemer and budesonide foam progressed during 2009. In August, we completed the dose selection stage (Stage 1) of the ADVENT trial,
our Phase 3 trial of crofelemer for the treatment of chronic diarrhea in people living with HIV, or HIV–associated diarrhea, and initiated
the final stage (Stage 2). Stage 2 of ADVENT involves the enrollment of 150 additional patients with HIV–associated diarrhea. Enrollment for
Stage 2 is anticipated to be completed in the first half of 2010, and currently we anticipate filing the crofelemer NDA during the second half of
2010. The FDA reviewed and granted the protocol for this trial as a Special Protocol Assessment, or SPA, and granted the crofelemer IND fast track
designation.
"In early October we submitted an IND to the FDA to conduct two identically designed Phase 3, multi–center, double–blind, randomized, placebo–controlled
studies evaluating the effectiveness and safety of budesonide rectal foam for the treatment of mild to moderate ulcerative proctitis
or proctosigmoiditis. The studies are designed to compare 2mg/25mL budesonide foam dosed twice–a–day (BID) for 2 weeks followed by
once–a–day (QD) dosing for 4 weeks, versus placebo foam. Each study is targeted to enroll approximately 430 subjects. We initiated enrollment
in late December 2009 and are targeting to enroll 75 percent of the subjects by the end of 2010.
"We look forward to continued growth and expansion during 2010 and beyond. We plan to continue to execute our business strategy by in–licensing late–stage and marketed products, developing the products in our pipeline and ensuring that our marketed products are provided with the attention
and support required to achieve success."
The Company will host a conference call at 5:00 p.m. ET, on Tuesday, March 9, 2010. Interested parties can access the conference call by way of web cast
or telephone. The live web cast will be available at www.salix.com.
A replay of the web cast will be available at the same location. The telephone numbers to access the live conference call are (888) 293–6979
(U.S. and Canada) or (719) 325–2320 (international.) The telephone numbers to access the replay of the call are (888) 203–1112
(U.S. and Canada) or (719) 457–0820 (international.) The access code for the replay is 1412391.
Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal
diseases. Salix's strategy is to in–license late–stage or marketed proprietary therapeutic drugs, complete any required
development and regulatory submission of these products, and market them through the Company's gastroenterology specialty sales and marketing team.
Salix markets XIFAXAN® (rifaximin) tablets 200 mg, MOVIPREP® (PEG 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride,
Sodium Ascorbate and Ascorbic Acid for Oral Solution), OSMOPREP® (sodium phosphate monobasic monohydrate, USP and sodium phosphate
dibasic anhydrous, USP) Tablets, VISICOL® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP)
Tablets, APRISO™ (mesalamine) extended–release capsules 0.375 g, METOZOLV™ ODT (metoclopramide HCl), PEPCID®
(famotidine) for Oral Suspension, Oral Suspension DIURIL® (Chlorothiazide), AZASAN® (Azathioprine)
Tablets, USP, 75/100 mg, ANUSOL–HC® 2.5% (Hydrocortisone Cream, USP), ANUSOL–HC® 25 mg Suppository (Hydrocortisone
Acetate), PROCTOCORT® Cream (Hydrocortisone Cream, USP) 1% and PROCTOCORT® Suppository (Hydrocortisone Acetate
Rectal Suppositories) 30 mg. Crofelemer, budesonide foam and rifaximin for additional indications are under development.
For full prescribing information and important safety information, including BOXED WARNINGS for VISICOL, OSMOPREP and METOZOLV, on Salix products, please
visit www.salix.com where the Company promptly posts press releases,
SEC filings and other important information or contact the Company at 919 862–1000.
Salix trades on the NASDAQ Global Select Market under the ticker symbol "SLXP".
For more information please visit our web site at www.salix.com . Information on our web site is not incorporated in
our SEC filings.
Table Follows
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Fourth Quarter 2009 Statement - Fiscal Year 2009 - Unaudited (PDF 17KB)
Please Note: The materials provided herein contain projections and other forward–looking statements regarding future events. Such statements are
just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties
include, among others: our need to return to profitability; market acceptance for approved products; the unpredictability of the duration
and results of regulatory review of New Drug Applications and Investigational NDAs; the cost, timing and results of clinical trials and other development
activities involving pharmaceutical products; generic and other competition; litigation and the possible impairment of, or inability to obtain,
intellectual property rights and the costs of obtaining such rights from third parties; revenue recognition and other critical accounting policies
and the need to acquire new products. The reader is referred to the documents that the Company files from time to time with the Securities and Exchange Commission.
back to news
APRISO™ is a locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis in patients 18 years and older.
APRISO is contraindicated in patients with hypersensitivity to salicylates, aminosalicylates, or to any of the components of APRISO capsules.
The recommended dose of APRISO is four 0.375 g capsules once daily in the morning (1.5 g/day) with or without food. Because dissolution of the coating of APRISO
granules depends on pH, APRISO should not be coadministered with antacids. Patients with phenylketonuria should be aware that APRISO contains aspartame,
equivalent to 0.56 mg of phenylalanine. In two well-controlled clinical trials, the most common treatment-related adverse events occurring in at least 3%
of adult patients taking 1.5 g/day of APRISO were headache (11% vs. 8% for placebo), diarrhea (8% vs. 7% for placebo), upper abdominal pain (5% vs 3% for placebo),
nausea (4% vs 3% for placebo), nasopharyngitis (4% vs 3% for placebo), influenza and influenza-like illness (4% vs 4% for placebo) and sinusitis (3% vs 3% for placebo).
For complete Prescribing Information, please click here.
MOVIPREP® (PEG-3350, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate and ascorbic acid for oral solution) is indicated for cleansing of the
colon as a preparation for colonoscopy in adults 18 years of age or older. MOVIPREP is contraindicated in patients who have had a severe hypersensitivity reaction
to any of its components. MOVIPREP should be used with caution in patients using concomitant medications that increase the risk of electrolyte abnormalities, in patients with known or suspected hyponatremia,
severe ulcerative colitis, ileus, gastrointestinal obstruction or perforation, gastric retention, toxic colitis, toxic megacolon, or glucose-6-phosphate dehydrogenase deficiency. In clinical trials, abdominal
distention, anal discomfort, thirst, nausea, and abdominal pain were the most common adverse reactions to MOVIPREP administration. MOVIPREP contains a maximum of 2.33 mg of phenylalanine per treatment.
Consult with your physician to see if this product is right for you.
For complete Prescribing Information, please click here.
Important Safety Information about OSMOPREP
There have been rare, but serious reports of acute phosphate nephropathy in patients who received oral sodium phosphate products for colon cleansing prior
to colonoscopy. Some cases have resulted in permanent impairment of renal function and some patients required long–term dialysis. While some
cases have occurred in patients without identifiable risk factors, patients at increased risk of acute phosphate nephropathy may include those with
increased age, hypovolemia, increased bowel transit time (such as bowel obstruction), active colitis, or baseline kidney disease, and those using
medicines that affect renal perfusion or function (such as diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers
[ARBs], and possibly nonsteroidal anti–inflammatory drugs [NSAIDs]).
It is important to use the dose and dosing regimen as recommended (PM/AM split dose).
OSMOPREP® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP) Tablets are indicated for cleansing
of the colon as a preparation for colonoscopy in adults 18 years of age or older. Considerable caution should be advised before OSMOPREP is used in
patients with severe renal insufficiency, congestive heart failure, ascites, unstable angina, gastric retention, ileus, severe chronic constipation,
bowel perforation, toxic megacolon, gastric bypass or stapling surgery, or hypomotility syndrome. Use with caution in patients with impaired renal
function, patients with a history of seizures or at higher risk of seizure, patients with higher risk of cardiac arrhythmias, known or suspected electrolyte
disturbances (such as dehydration), or people taking drugs that affect electrolyte levels. Patients with electrolyte abnormalities such as
hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia should have their electrolytes corrected before treatment with OSMOPREP.
OSMOPREP is contraindicated in patients with a known allergy or hypersensitivity to sodium phosphate salts or any of its ingredients, and in patients with
biopsy–proven acute phosphate nephropathy. In clinical trials, the most commonly reported adverse reactions (reporting frequency >3%) were
abdominal bloating, nausea, abdominal pain, and vomiting. It is recommended that patients receiving OSMOPREP be advised to adequately hydrate before,
during, and after the use of OsmoPrep.
For complete Prescribing Information for OSMOPREP including BOXED WARNING, please click here.
Important Safety Information about XIFAXAN 550 mg
XIFAXAN® 550 mg is indicated for reduction in risk of overt hepatic encephalopathy (HE) recurrence in patients ≥18 years of age. In the trials of XIFAXAN for HE, 91% of the patients were using lactulose concomitantly. XIFAXAN has not been studied in patients with MELD scores >25, and only 8.6% of patients in the controlled trial had MELD scores over 19. There is increased systemic exposure in patients with more severe hepatic dysfunction. Therefore, caution should be exercised when administering XIFAXAN to patients with severe hepatic impairment (Child-Pugh C).
XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile–associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon which may lead to overgrowth of C difficile. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C difficile may need to be discontinued.
The most common adverse reactions occurring in >8% of patients in the clinical study were edema peripheral (15%), nausea (14%), dizziness (13%), fatigue (12%), ascites (11%), muscle spasms (9%), pruritus (9%), and abdominal pain (9%).
For complete Prescribing Information, please click here.
Important Safety Information about METOZOLV ODT
Treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible.
The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose.
Metoclopramide therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia.
There is no known treatment for tardive dyskinesia. In some patients, symptoms may lessen or resolve after metoclopramide treatment is stopped.
Treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.
METOZOLV® ODT
(metoclopramide HCl) is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal
reflux disease (GERD) who fail to respond to conventional therapy and for the relief of symptoms associated with acute and
recurrent diabetic gastroparesis (diabetic gastric stasis) in adults. Therapy should not exceed 12 weeks in duration. Take on
an empty stomach up to four times daily, at least 30 minutes before eating and at bedtime.
METOZOLV ODT is contraindicated in patients with intestinal obstruction, hemorrhage, or perforation; pheochromocytoma;
known sensitivity or intolerance to metoclopramide; epilepsy; or are receiving concomitant medications with extrapyramidal reactions.
Extrapyramidal symptoms (EPS), manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the
usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide,
occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at higher doses.
Drug-induced Parkinsonism can occur during metoclopramide therapy, more commonly within the first 6 months after beginning treatment,
but also after longer periods. Patients with a history of Parkinson’s disease should be given metoclopramide cautiously, if at all,
since such patients can experience exacerbation of Parkinsonian symptoms when taking metoclopramide.
There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated
with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability.
The management of NMS should include immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy.
Depression associated with metoclopramide use has occurred in patients with and without a history of depression.
For those patients with a prior history of depression, metoclopramide should only be given if the expected benefits outweigh the potential risks.
In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; hence, caution should be exercised
when metoclopramide is used in patients with hypertension. Any rapid rise in blood pressure associated with METOZOLV ODT use should result in immediate
cessation of metoclopramide use in those patients.
Since metoclopramide produces a transient increase in plasma aldosterone, patients with cirrhosis or congestive heart failure may be at risk of developing
fluid retention and volume overload. If these side effects occur at any time in any patients during metoclopramide therapy, the drug should be discontinued.
Adverse reactions, especially those involving the nervous system, may occur after stopping the use of METOZOLV ODT.
In clinical studies, the most frequently reported adverse events (≥2% occurrence) were headache, nausea, fatigue, somnolence, and vomiting.
Full Prescribing Information for METOZOLV ODT, including BOXED WARNING.