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Valeant Pharmaceuticals Developing Intranasal Diazepam for the At-Home Treatment of Emergency Seizures.


ALISO VIEJO, Calif. -- Valeant Pharmaceuticals International Valeant Pharmaceuticals International is a pharmaceutical company with activities spanning the drug discovery pipeline from target identification through clinical trials and commercialization.  (NYSE NYSE

See: New York Stock Exchange
:VRX) today announced that it is developing an intranasal form of delivery for diazepam diazepam /di·az·e·pam/ (di-az´e-pam) a benzodiazepine used as an antianxiety agent, sedative, antipanic agent, antitremor agent, skeletal muscle relaxant, anticonvulsant, and in the management of alcohol withdrawal symptoms.  for the treatment of seizure emergencies in children and adults, in conjunction with researchers from the University of Minnesota (body, education) University of Minnesota - The home of Gopher.

http://umn.edu/.

Address: Minneapolis, Minnesota, USA.
. Valeant currently markets Diastat[R] AcuDial[TM] (diazepam rectal gel) -- the only FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approved at-home treatment for the acute management of increased seizure activity.

"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 Morbidity and Mortality can refer to:
  • Morbidity & Mortality, a term used in medicine
  • Morbidity and Mortality Weekly Report, a medical publication
See also
  • Morbidity, a medical term
  • Mortality, a medical term
, 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."

About Epilepsy

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 somnolence /som·no·lence/ (som´no-lens) drowsiness or sleepiness, particularly in excess.

som·no·lence
n.
1. A state of drowsiness; sleepiness.

2.
 (23%). Less frequent adverse events reported were dizziness, headache pain, vasodilatation vasodilatation /vaso·di·la·ta·tion/ (-di?lah-ta´shun) vasodilation.

vasodilatation, vasodilation

a state of increased caliber of blood vessels.
, diarrhea, ataxia ataxia (ətăk`sēə), lack of coordination of the voluntary muscles resulting in irregular movements of the body. Ataxia can be brought on by an injury, infection, or degenerative disease of the central nervous system, e.g. , euphoria, incoordination incoordination /in·co·or·di·na·tion/ (in?ko-or?di-na´shun) ataxia.

in·co·or·di·na·tion
n.
See ataxia.
, 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 paresthesia /par·es·the·sia/ (par?es-the´zhah) morbid or perverted sensation; an abnormal sensation, as burning, prickling, formication, etc.

par·es·the·sia or par·aes·the·sia
n.
, diplopia diplopia /di·plo·pia/ (di-plo´pe-ah) the perception of two images of a single object.

binocular 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.

About Valeant

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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Jan 25, 2007
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