Why use Metozolv ODT?

Metozolv ODT combines the efficacy of established metoclopramide medication with the convenience of a tablet that rapidly* melts on the tongue

The only orally disintegrating prokinetic available1-3
Metoclopramide has been used for nearly 30 years1,4
Numerous clinical studies have proven the efficacy of metoclopramide in diabetic gastroparesis and refractory GERD5-11
Rapidly* melts on the tongue and can be taken anywhere, without liquid

Patients prefer orally disintegrating tablets12-18

of patients said that the use of orally disintegrating tablets was convenient or very convenient12†

of patients favored the ease of compliance of orally disintegrating tablets versus 7% who favored conventional tablets13‡

of patients who have difficulty swallowing preferred orally disintegrating tablets to conventional tablets14§

Metozolv ODT features Zydis® technology

Zydis® technology allows Metozolv ODT to rapidly* melt on the tongue19
Zydis® technology allows patients to conveniently take Metozolv ODT when liquid is not available or if they have difficulty swallowing
75% of subjects expressed a preference for the orally disintegrating Zydis® formulation compared with a conventional tablet15II

Clinically proven to improve symptoms of diabetic gastroparesis5-9

Nausea and postprandial fullness significantly improved (Figures 1 and 2)5
Reduced symptoms and improved gastric emptying6,7

Figure 1. Improvement in symptom severity rating. Patients who had an initial rating of moderate or more for fullness showed improvement after use of metoclopramide versus placebo.5¶

Figure 2. Improvement in symptom severity rating. Patients who had an initial rating of moderate or more for nausea showed improvement after use of metoclopramide versus placebo.5¶

Clinically proven to improve symptoms of refractory GERD10,11

Decreases episodes of daytime and nighttime heartburn and vomiting10
May reduce the need for antacids10**
Increases the speed at which food moves through the digestive system11

Metozolv ODT dosing information

Available in 5-mg and 10-mg orally disintegrating tablets1
Can be taken up to 4 times a day, at least 30 minutes before each meal and at bedtime1

Discover the convenience of Metozolv ODT See examples of patients who may benefit from Metozolv ODT What is Zydis® technology?

*Metozolv ODT disintegrates on the tongue in a median of 53.5 seconds (mean ± standard deviation, 76.8 ± 110.6 seconds).1

†In a multicenter, observational, cross-sectional study of 734 men and women aged 18 years or older with lansoprazole orally disintegrating tablets.

‡In a multicenter, open-label, sequential study of 60 men and women aged 18 years or older who received carbidopa-levodopa tablets, patients were asked if the tablets "made it more convenient to comply with dosing schedule?"

§A randomized, single-group, crossover study of 36 men and women aged 21 years or older with RapiTab™ orally disintegrating tablets.

RapiTab is a trademark of Schwarz Pharma Inc.

IIIn a randomized, single-blind trial of 450 adult men and women (aged 21 to 83 years) with famotidine wafers.

¶In a 3-week, double-blind, placebo-controlled study of 44 men and women (aged 21-67 years) with oral metoclopramide tablets.

**In a double-blind trial, there was a 61% reduction in antacid ingested by the metoclopramide-treated group compared with a 20% reduction in the placebo group (P<0.05).

Zydis is a registered trademark of Catalent Pharma Solutions.

References: 1. METOZOLV ODT [package insert]. Morrisville, NC: Salix Pharmaceuticals, Inc; 2009. 2. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=REGLAN. Accessed May 6, 2009. 3. Overview. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=METOCLOPRAMIDE%20HYDROCHLORIDE. Accessed May 6, 2009. 4. Overview. Reglan (NDA # 017854). US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Overview&DrugName=REGLAN. Accessed December 12, 2008. 5. McCallum RW, Ricci DA, Rakatansky H, et al. A multicenter placebo-controlled clinical trial of oral metoclopramide in diabetic gastroparesis. Diabetes Care. 1983;6:463-467. 6. Ricci DA, Saltzman MB, Meyer C, Callachan C, McCallum RW. Effect of metoclopramide in diabetic gastroparesis. J Clin Gastroenterol. 1985;7:25-32. 7. Snape WJ, Battle WM, Schwartz SS, Braunstein SN, Goldstein HA, Alavi A. Metoclopramide to treat gastroparesis due to diabetes mellitus: a double-blind, controlled trial. Ann Intern Med. 1982;96;444-446. 8. Erbas T, Varoglu E, Erbas B, Tastekin G, Akalin S. Comparison of metoclopramide and erythromycin in the treatment of diabetic gastroparesis. Diabetes Care. 1993;16:1511-1514. 9. Patterson D, Abell T, Rothstein R, Koch K, Barnett J. A double-blind multicenter comparison of domperidone and metoclopramide in the treatment of diabetic patients with symptoms of gastroparesis. Am J Gastroenterol. 1999;94:1230-1234. 10. McCallum RW, Fink SM, Winnan GR, Avella J, Callachan C. Metoclopramide in gastroesophageal reflux disease: rationale for its use and results of a double-blind trial. Am J Gastroenterol. 1984;79:165-172. 11. McCallum RW, Fink SM, Lerner E, Berkowitz DM. Effects of metoclopramide and bethanechol on delayed gastric emptying present in gastroesophageal reflux patients. Gastroenterology. 1983;84:1573-1577. 12. de Argila CM, Ponce J, Márquez E, et al. Acceptability of lansoprazole orally disintegrating tablets in patients with gastro-oesophageal reflux disease. Clin Drug Invest. 2007;27:765-770. 13. Nausieda PA, Pfeiffer RF, Tagliati M, Kastenholz KV, DeRoche C, Slevin JT. A multicenter, open-label, sequential study comparing preferences for carbidopa-levodopa orally disintegrating tablets and conventional tablets in subjects with Parkinson’s disease. Clin Ther. 2005;27:58-63. 14. Carnaby-Mann G, Crary M. Pill swallowing by adults with dysphagia. Arch Otolaryngol Head Neck Surg. 2005;131:970-975. 15. Schwartz JI, Yeh KC, Berger ML, et al. Novel oral medication delivery system for famotidine. J Clin Pharmacol. 1995;35:362-367. 16. Dowson A, Bundy M, Salt R, Kilminster S. Patient preference for triptan formulations: a prospective study with zolmitriptan. Headache. 2007;47:1144-1151. 17. Dowson AJ, Almqvist P. Part III: the convenience of, and patient preference for, zolmitriptan orally disintegrating tablet. Curr Med Res Opin. 2005;21:S13-S17. 18. Clarke A, Johnson ES, Mallard N, et al. A new low-dose formulation of selegiline: clinical efficacy, patient preference and selectivity for MAO-B inhibition. J Neural Transm. 2003;110:1257-1271. 19. Zydis fast-dissolve technology. Catalent. Available at: http://www.catalent.com/drug/oral/zydis/. Accessed December 5, 2008.

IMPORTANT SAFETY INFORMATION

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 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. 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. METOZOLV ODT should be used with caution in patients showing acute dystonic reactions, drug-induced Parkinsonism, or other extrapyramidal symptoms; neuroleptic malignant syndrome; with a prior history of depression; hypertension; congestive heart failure and ventricular arrhythmia. Patients may experience withdrawal symptoms 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.

Please see accompanying full Prescribing Information for Metozolv ODT, including BOXED WARNING.