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Biovail Receives Tentative Approval From FDA for Zolpidem ODT for Sleep Disorders

TORONTO, May 27, 2005 - Biovail Corporation (NYSE:BVF)(TSX:BVF) announced today that it has received tentative approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for its oral disintegrating tablet (ODT) formulation of zolpidem tartrate, which is indicated for the short-term treatment of insomnia.

The FDA's tentative approval is based upon its conclusion that Zolpidem ODT is safe and effective for use, according to the product labeling provided by Biovail. Final approval for Zolpidem ODT cannot be made effective until the expiration of patent protection for Ambien in October 2006, which is held by Sanofi-Aventis.

Zolpidem ODT is the first Biovail formulation tentatively approved by the FDA that utilizes Biovail's patented Ceform(R) technology.

"For some people who experience daytime sleepiness and impaired performance as a result of transient insomnia, the short-term use of short-acting medication for sleep disorders may improve sleep and, in turn, next-day alertness," said Dr. Douglas Squires, Chief Executive Officer of Biovail Corporation. "Given that insomnia tends to occur more frequently in patients over the age of 60, we believe that our ODT version of zolpidem tartrate will provide health-care practitioners, upon final approval, with another viable treatment option to treat transient and intermittent sleep difficulties."

It is expected that Biovail's oral disintegrating tablet versions of immediate-release zolpidem will offer a number of potential advantages. More specifically, patients will benefit from the convenience of this formulation manufactured with Biovail's FlashDose(R) technology - particularly those who have difficulty swallowing tablets, or those who may not, or do not, always have access to water. Studies in the U.S. have indicated that up to 40% of adults have experienced problems with swallowing tablets - and a significant proportion of those fail to comply properly with their prescribed and ongoing dosage.

Market Opportunity
Biovail believes a considerable opportunity exists in the U.S. for its oral disintegrating tablet version of immediate-release zolpidem tartrate among non-benzodiazepine (non-barbiturate) market for sleeping aids to treat insomnia, where sales for the 12 months ended March 31, 2005 were $2.2 billion. Over the same period, zolpidem generated revenues of $1.99 billion and 26.2 million prescriptions.

Biovail expects to enter into an agreement with a strategic partner for the marketing and distribution of the product in the U.S. Subject to regulatory approvals, Biovail anticipates it will manufacture and supply all the partner company's trade and sample supply requirements. At this time, the FDA is willing to allow Biovail to choose a trademark prior to the commercialization of the product.

Zolpidem is currently marketed in the U.S. under the brand name, Ambien, by Sanofi-Aventis. The patent, which is held by Sanofi-Aventis, expires in October 2006. Therefore, Sanofi-Aventis can effectively block commercialization of Biovail's Zolpidem ODT prior to this date.

How Zolpidem Works
Zolpidem belongs to a class of medicines that affects the central nervous system, called sedative hypnotics. Zolpidem is closely related to a family of drugs called benzodiazepines. These drugs cause sedation, muscle relaxation, act as anti-convulsants (anti-seizure), and have anti-anxiety properties. Zolpidem has selectivity in that it has little of the muscle relaxant or anti-seizure effect and more of the sedative effect.

Zolpidem ODT (zolpidem tartrate oral disintegrating tablets) is a non-benzodiazepine hypnotic of the imidazopyridine class in an oral disintegrating formulation using a FlashDose(R) tablet formulation base. Zolpidem ODT is a medically useful formulation that disintegrates in the mouth in seconds, and may be taken with or without water.

Safety Information
Since sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after seven to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness, which should be evaluated.

Dosage
The recommended dose for adults is 10mg immediately before bedtime, and should not exceed 10mg. Elderly or debilitated patients, and patients with hepatic insufficiency, may be especially sensitive to the effects of Zolpidem ODT. An initial 5mg dose is recommended for these patients.

About Biovail Corporation
Biovail Corporation is specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies.

Posted: May 2005

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