Valeant Pharmaceuticals Developing Intranasal Diazepam for the At-Home Treatment of Emergency Seizures.
"We appreciate the commitment by Valeant to improve the treatment of epilepsy," said James Cloyd, Pharm.D., Professor and Director, Center for Orphan Drug Research at the University of Minnesota. "Although a relatively small percentage of patients with epilepsy have seizure emergencies, they result in devastating effects on a patient's health. Delays in treatment may result in refractory seizures, increased morbidity and mortality, and higher medical costs. The availability of safe, effective and easily administered drug therapies allowing patients and their caregivers to initiate treatment at the onset of a seizure emergency will improve the overall management of epilepsy."
"Valeant is excited to be collaborating with the University of Minnesota on the development of this new delivery system for diazepam," said Wesley P. Wheeler, Valeant's President of North America and Global Product Development. "A novel, nasal delivery system would provide patients and their caregivers a convenient alternative to our current Diastat AcuDial, to manage seizure emergencies outside the hospital or emergency department. Valeant is committed to supporting the development of new options for epilepsy patients through collaborations such as this with the University of Minnesota and our own development of retigabine, currently in Phase 3 clinical development."
Epilepsy is one of the most common neurological diseases, affecting 2.7 million Americans of all ages. Approximately 181,000 new cases of seizures and epilepsy occur each year, with 10 percent of the American population experiencing a seizure in their lifetime.
Important Diastat AcuDial (diazepam rectal gel) Information
Diastat (diazepam rectal gel) is a gel formulation of diazepam intended for rectal administration in the management of selected, refractory, patients with epilepsy, on stable regimens of anti-epileptic drugs (AEDs), who require intermittent use of diazepam to control bouts of increased seizure activity for patients two years and older. Diastat AcuDial is supplied in a twin pack of pre-filled configurations:
-- 10 mg delivery system with a 4.4 cm tip delivers doses of 5, 7.5, and 10 mg
-- 20 mg delivery system with a 6.0 cm tip delivers doses of 10, 12.5, 15, 17.5, and 20 mg
In pivotal trials with Diastat, the most frequent adverse event reported was somnolence (23%). Less frequent adverse events reported were dizziness, headache pain, vasodilatation, diarrhea, ataxia, euphoria, incoordination, asthma, rash, abdominal pain, nervousness and rhinitis (1%-5%).
For full prescribing information, please visit www.diastat.com, or for product-related questions, call Valeant Pharmaceuticals International at 1-877-361-2719.
Important Retigabine Information
The most common side effects associated with retigabine to date include somnolence, dizziness, confusion, speech disorder, vertigo, tremor, amnesia, abnormal thinking, abnormal gait, paresthesia, diplopia, incoordination, nervousness, abnormal vision, asthenia, headache, nausea and diarrhea.
Retigabine is an investigational compound that has not been found by the Food and Drug Administration (FDA) or any other regulatory agency to be safe or effective in the diagnosis, mitigation, treatment or cure of any disease or illness. It may not be sold or promoted in the United States unless and until FDA has approved a New Drug Application. Similar restrictions apply in other countries.
Valeant Pharmaceuticals International (NYSE:VRX) is a global specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology, infectious disease and dermatology. More information about Valeant can be found at www.valeant.com.
Diastat and Diastat AcuDial are trademarks or registered trademarks of Valeant Pharmaceuticals International or its related companies. All other trademarks are the trademarks or registered trademarks of their respective owners.
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|Date:||Jan 25, 2007|
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