P&T COMMUNITY
 
MediMedia Managed Markets
Our
Other
Journal
Managed Care magazine
P&T Community, The Online Resource for P&T Decision Makers
Login / Register
Join Us  Facebook  Twitter  Linked In

 

News Categories

 

 

 

Fycompa (Perampanel) Gets FDA Nod for Epilepsy Seizures

Agency recommends controlled substance classification (Oct. 23)

The FDA has approved Fycompa (perampanel, Eisai) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients aged 12 years and older with epilepsy.

Fycompa is a noncompetitive AMPA (alpha-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid)-type glutamate receptor antagonist. The drug reduces neuronal hyperexcitation associated with seizures by inhibiting glutamate activity at postsynaptic AMPA receptors.

The FDA approval was primarily based on clinical data from three pivotal phase III, global, randomized, double-blind, placebo-controlled, dose-escalation trials that evaluated a total of 1,480 patients aged 12 years and older with partial-onset seizures. These studies demonstrated that Fycompa, as an adjunctive therapy, significantly reduced the frequency of seizures in patients with partial-onset seizures with or without secondary generalized seizures.

In Study 304, the 50% responder rates in the intention-to-treat (ITT) population were 37.6% (P = 0.0760) and 36.1% (P = 0.0914) for Fycompa 8 mg and 12 mg, respectively, versus 26.4% for placebo. The median percentage changes in seizure frequency in the ITT population were –26.3% (P = 0.0261) and –34.5% (P = 0.0158) for Fycompa 8 mg and 12 mg, respectively, versus –21.0% for placebo.

In Study 305, the 50% responder rates in the ITT population were 33.3% (P = 0.0018) and 33.9% (P = 0.0006) for Fycompa 8 mg and 12 mg, respectively, versus 14.7% for placebo. The median percentage changes in seizure frequency in the ITT population were: –30.5% (P = 0.0008) and –17.6% (P = 0.0105) for Fycompa 8 mg and 12 mg, respectively, versus –9.7% for placebo.

In Study 306, the 50% responder rates in the ITT population were 20.6% (P = 0.4863), 28.5% (P = 0.0132), and 34.9% (P = 0.0003) for Fycompa 2 mg, 4 mg, and 8 mg, respectively, versus 17.9% for placebo. The median percentage changes in seizure frequency in the ITT population were –13.6% (P = 0.4197), –23.3% (P = 0.0026), and –30.8% (P < 0.0001) for Fycompa 2 mg, 4 mg, and 8 mg, respectively, versus –10.7% for placebo.

The most commonly reported adverse events in these trials included dizziness, somnolence, fatigue, irritability, falls, nausea, ataxia, balance disorder, gait disturbance, vertigo, and weight gain. Serious or life-threatening psychiatric problems also occurred more often in patients treated with Fycompa.

The FDA has recommended that Fycompa be classified by the U.S. Drug Enforcement Administration (DEA) as a scheduled drug under the country’s Controlled Substances Act. Once the DEA has provided the final scheduling designation, the drug’s manufacturer (Eisai) will announce when Fycompa will be available to physicians in the U.S.

Source: Eisai Inc., October 23, 2012.

More stories