New Indication for Fycompa
July 26, 2017 – The U.S. FDA has approved a new indication for Fycompa® (perampanel), manufactured by Eisai, Inc., for use as a single agent to treat patients 12 years of age and older with epilepsy who have partial-onset seizures with or without secondarily generalized seizures. The only drug in its class, Fycompa is a selective, non-competitive ionotropic alpha-amino-3-hydroxy-5-methyl-4-isoxazoleproprionic acid (AMPA) receptor antagonist. The FDA originally granted approval in October 2012 for the same types of seizures, but only in combination with other anti-epileptic drugs. Fycompa has an additional indication as part of a combination regimen to treat patients at least 12 years of age who have primary generalized tonic-clonic seizures.
Fycompa is available in oral tablets and an oral suspension. Recommended dosing is 8mg to 12mg once a day at bedtime. The drug includes a medication guide and black box warning that its use has been associated with behavioral, mood, or personality changes, and/or psychiatric effects, such as aggression, anger, anxiety, irritability, or hallucinations. Some patients who use Fycompa have experienced thoughts of self-harm or causing harm to others. A C-III controlled substance, the drug has the potential to lead to dependence and/or abuse.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.