Acorda Therapeutics, Inc. (Nasdaq:
) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for PLUMIAZ
(diazepam) Nasal Spray for the treatment of people with epilepsy who experience
A CRL is a communication from the FDA that informs a company that their review of the NDA is complete and the application cannot be approved in its present form. The Company is currently developing a response to address the items outlined in the letter.
“There is an urgent need for new treatments for people with epilepsy who experience cluster seizures. We are committed to the development and commercialization of PLUMIAZ, a potential therapeutic option for these individuals,” said Ron Cohen, M.D., Acorda’s President and CEO. “We are evaluating the Complete Response Letter and expect to work closely with the FDA to address the items outlined in the letter and refile the NDA for PLUMIAZ. We expect to provide further detail as our discussions with the FDA progress.”
Based on the requirements for approval outlined in the letter, the Company does not expect PLUMIAZ to receive FDA approval in 2014.
Of the approximately 2.8 million people in the United States with epilepsy, it is estimated that about 175,000 experience cluster seizures, also known as acute repetitive seizures or bouts of increased seizure activity. These patients may experience cluster seizures even though they generally are on stable regimens of antiepileptic medications (AEDs). Currently, many of these individuals do not find the currently available outpatient therapy acceptable and default to emergency room care or no care at all. PLUMIAZ potentially offers a more viable treatment option. PLUMIAZ has received orphan drug designation for the treatment of cluster seizures.
Epilepsy is a neurological condition that produces seizures affecting a variety of mental and physical functions. Seizures are symptoms of abnormal brain activity, and occur when a brief, strong surge of electrical activity affects part or all of the brain.