Valeant Pharmaceuticals Unveils Diastat AcuDial

COSTA MESA, Calif., September 19, 2005 -- Valeant Pharmaceuticals International (NYSE:VRX) today announced the approval of Diastat AcuDial (diazepam rectal gel) -- the only FDA approved at-home treatment for the safe and immediate management of emergency seizures. Diastat AcuDial is an exclusive proprietary drug delivery system that gives physicians and pharmacists greater ability to adapt dosage based on individual patient needs. Diastat AcuDial will be available in pharmacies nationwide in early October 2005.

Timothy C. Tyson, Valeant’s president and chief executive officer, said, "Diastat is a unique product that provides caregivers with a fast and safe treatment for epilepsy patients. As the only product approved for treating emergency seizures outside of a hospital, Diastat AcuDial takes these benefits to a new level with a flexible, easy-to-use delivery system that enables immediate treatment of seizures by a non-medically trained caregiver. This product was designed with input from physicians, pharmacists and patients and we believe that it will be very well received."

"When a patient begins to have prolonged or recurrent seizures outside of their normal patterns, it’s a medical emergency that needs to be treated immediately," said Dr. James W. Wheless, professor and chief of pediatric neurology at the University of Tennessee Health Sciences Center. "In the United States, the amount of time that typically elapses between the onset of a seizure and a patient receiving treatment at a hospital can exceed one hour. That’s too long for this type of emergency. AcuDial is a safe, effective treatment, which is a significant patient advantage."

The Diastat AcuDial delivery system incorporates the ability to dial, set and lock specific doses in two configurations delivering doses ranging from 5 to 20 mg, and is easily administered by any non-medical caregiver. The system requires no refrigeration or special handling, so it can be stored in the home, office or taken along when traveling.

Valeant’s neurosciences business has gained significant momentum over the past year, beginning with the U.S. re-launch of Tasmar in July 2004 and the anticipated launch of Zelapar in late 2005. The company’s growth continued with the acquisition of Xcel Pharmaceuticals earlier this year.

About Epilepsy

The Epilepsy Foundation of America estimates that 2.5 million Americans suffer from epilepsy1 and that approximately 30 percent of those who suffer from this difficult condition are not able to control their seizures with existing maintenance therapies2. Approximately 42,000 deaths occur annually due to epilepsy3. Of the 181,000 new cases diagnosed each year, 58 percent are treated in an emergency room in the first year and 40 percent are hospitalized at least once1. Studies have shown that prolonged or repetitive seizures can cause neurological damage. Prolonged seizures can dramatically increase the risk of death, mental handicap, memory loss and changes in neuropsychological function.

Important Diastat (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

Important Safety Information

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%).

References:

  1. Epilepsy Foundation of America.
    Available at: www.epilepsyfoundation.org/answerplace/statistics.cfm.
    Accessed 2-14-05.
  2. Kwan P, et al. N Engl J Med. 2000;342:314-319.
  3. Pellock JM. Hosp Med. 1999;60:43-49.

Source: Valeant Pharmaceuticals

Posted: September 2005


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