BioDelivery: Study of Emezine buccal tablets promising, may offer option for nausea patients

By E. Janene Geiss

Philadelphia, Dec. 7 - BioDelivery Sciences International Inc. announced Wednesday that a study of Emezine's buccal tablet formulation for severe nausea and vomiting is promising and could be an alternative for patients who can't swallow a product during a period of nausea.

The findings, published in the December issue of the Journal of Clinical Pharmacology, showed that in the pharmokinetic study, plasma concentrations of Emezine's active ingredient, prochlorperazine, were more than twice as high and less variable than those obtained from a standard oral tablet, according to a company news release.

Emezine, a dissolving tablet placed between the lip and gum known as the buccal area, avoids the need for a patient to swallow a product during a period of nausea.

The company said it offers a more patient-friendly alternative to injections and rectal suppositories for patients who have post-operative nausea, vomiting and nausea due to chemotherapy and viral infections such as the flu.

The company submitted a New Drug Application on Emezine to the Food and Drug Administration in April 2005.

The FDA has said it will rule on the approvability of the Emezine NDA no later than Feb. 28.

Prochlorperazine in other dosage forms is already FDA-approved for the treatment of severe nausea and vomiting.

"Our study in normal volunteers demonstrates the variability of oral prochlorperazine absorption, a situation that is likely even greater in the nauseated patient because of the associated delay in the movement of stomach contents and absorption of a drug that is swallowed orally. The buccal delivery of prochlorperazine with Emezine addresses these fundamental absorption issues because it is absorbed through the buccal mucosa in the mouth and is not swallowed," said Andrew Finn, executive vice president of clinical development and regulatory affairs and an author of the study, in the release.

The company licenses Emezine on an exclusive basis in the United States from Reckitt Benckiser Healthcare Ltd.

If approved, the Emezine tablets will be manufactured for BioDelivery by Reckitt Benckiser, which currently distributes Emezine in the United Kingdom, officials said.

The U.S. distribution of Emezine will be handled by Teamm Pharmaceuticals, a subsidiary of Accentia Biopharmaceuticals, Inc., officials said.

BioDelivery is a Morrisville, N.C., specialty biopharmaceutical company that is exploiting its licensed and patented drug-delivery technologies to develop and commercialize, either on its own or in partnerships, new formulations of proven therapeutics targeted at acute treatment of pain, anxiety, nausea and vomiting and infections.

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