Chorea Associated With Huntington's Disease Ovation - Nationwide Availability Of Xenazine (tetrabenazine) Tablets In U.S.

Main Category: Huntingtons Disease
Also Included In: Neurology / Neuroscience;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 25 Nov 2008 - 8:00 PDT

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OVATION Pharmaceuticals, Inc. announced today that Xenazine* (tetrabenazine) Tablets, an orphan drug recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of chorea associated with Huntington's disease (HD), is now available throughout the United States. Xenazine is the first and only FDA-approved treatment specifically developed for any HD-related symptom.

"For nearly 30 years, I have been treating HD patients with Xenazine through our ongoing research and investigational new drug programs and have seen the positive impact this medication can have in the management of chorea," said Dr. Joseph Jankovic, Distinguished Chair in Movement Disorders and Director of the Parkinson's Disease Center and Movement Disorders Clinic at Baylor College of Medicine. "The availability of Xenazine in the U.S. following FDA's recent approval represents a major advancement for the patients and caregivers in the HD community who, until now, have had no approved treatment options for this debilitating movement disorder."

Xenazine will be distributed throughout the United States via a specialty pharmacy network. This approach to distributing the medication is designed to both help streamline prescription fulfillment, as well as to provide specialized assistance to healthcare professionals, patients and caregivers, including addressing questions about the appropriate use of Xenazine. Upon approval of Xenazine, FDA determined that a Risk Evaluation and Mitigation Strategy (REMS) was necessary to ensure that the benefits of the drug outweigh the risks of depression and suicidality, to promote the informed prescribing and proper titration and dosing of Xenazine, and to minimize the risk of drug-drug interactions. Also as part of the program associated with the REMS, OVATION has begun the process of educating physicians, pharmacists, patients and their caregivers about the safe and effective use of the drug.

"The availability of Xenazine in the U.S. represents a major advancement for the HD community that until now had no FDA-approved treatments specifically developed for this devastating disease," said Jeffrey S. Aronin, President and Chief Executive Officer of OVATION. "In bringing this important product to market, we are pleased to be joining forces with the scientists, physicians and advocacy organizations who have worked so hard to make Xenazine a reality for patients. We share their commitment to ensuring that patients who will benefit from the medication will finally have access to it."

Commitment to Helping Patients Get Access to Xenazine

Through comprehensive financial patient support programs, Ovation and its partners are committed to covering the costs of Xenazine for all qualified patients whenever possible.

As part of its patient assistance program, uninsured patients may qualify to get Xenazine at no cost. Patients who are insured but have demonstrated a need for support with their co-pay or co-insurance costs may qualify for Ovation's cost-sharing assistance program.

Through the company's specialty pharmacy network, Ovation has also implemented a Patient Starter Rx Program to provide a starter supply of Xenazine free of charge to qualified patients while insurance authorization and reimbursement status are pending.

About Chorea

Chorea is the most common symptom of Huntington's disease, which affects approximately 25,000 people in the U.S. It is characterized by jerky, involuntary movements throughout the body, often appearing as writhing, twisting and turning in a constant, uncontrollable dance-like motion. As chorea progresses, the involuntary, jerk-like movements worsen, making it difficult for individuals to carry out voluntary movements associated with daily living, such as speaking, eating and dressing. Over time, chorea presents an increasing safety risk to HD patients, often resulting in the need for assistance and supervision, and even institutionalization. Currently, there is no known cure for HD and the disease is ultimately fatal.

About Xenazine

The precise mechanism by which Xenazine exerts its anti-chorea effects is unknown, but it is believed to be related to its effects as a reversible depletor of monoamines by inhibiting a molecule known as vesicular monoamine transporter 2 (VMAT2). Xenazine has received Orphan Drug status from the FDA.

The efficacy of Xenazine as a treatment for chorea associated with Huntington's disease was demonstrated in a randomized, double-blind, placebo-controlled multi-center trial with a treatment duration of 12 weeks. The primary efficacy endpoint was the Total Chorea Score, an item of the Unified Huntington's Disease Rating Scale (UHDRS). The treatment effect of 3.5 units was highly statistically significant. At one week after discontinuation of the study medication, the Total Chorea Scores of subjects receiving Xenazine returned to baseline.

Important Safety Information and Boxed Warning

Xenazine can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease. Anyone considering the use of Xenazine must balance the risks of depression and suicidality with the clinical need for control of choreiform movements. Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician.

Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington's disease. Xenazine is contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression.

Xenazine is also contraindicated in patients with impaired hepatic function, and in patients taking monoamine oxidase inhibitors or reserpine. At least 20 days should elapse after stopping reserpine before starting Xenazine. Although Xenazine has been shown to decrease the chorea associated with HD, it was also shown to cause slight worsening in mood, cognition, rigidity and functional capacity and prescribers should periodically re-evaluate the need for therapy. Some adverse effects such as depression, fatigue, insomnia, sedation/somnolence, parkinsonism, akathisia, QTc prolongation and interactions with CYP2D6 inhibitors may be dose dependent, and resolve or lessen with dose adjustment. The most frequent adverse events reported with Xenazine compared to placebo in a randomized, 12-week, placebo controlled clinical trial of HD subjects include sedation/somnolence (31% vs. 3%), fatigue (22% vs. 13%), insomnia (22% vs. 0%), depression (19% vs. 0%), akathisia (19% vs. 0%), anxiety (15% vs. 3%) and nausea (13% vs. 7%). For more information, please see full prescribing information including Boxed Warning or go to http://www.xenazineusa.com.

About OVATION Pharmaceuticals

OVATION is a fast-growing biopharmaceutical company that develops, manufactures and markets medically necessary therapies to satisfy unmet medical needs for patients with severe illnesses. Headquartered in Deerfield, Ill., with products available in more than 85 countries, OVATION is committed to having a significant impact on patients' lives through its focus on central nervous system, hematology/oncology, and hospital-based therapies. The four new launches the company expects over the next three years will largely be fueled by its late-stage CNS pipeline, which is one of the most robust in the industry. OVATION has been recognized for excellence in the global pharmaceutical and biotechnology industries with the 2006 and 2007 "Pharma Company of the Year" award from Scrip magazine for small to mid-sized enterprises. More information about the company, its products and full prescribing information may be found at http://www.ovationpharma.com.

* Trademark of Cambridge Laboratories (Ireland) Limited

OVATION Pharmaceuticals

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