The pediatric neurologist discussed the importance of the recent FDA approval of perampanel in pediatrics with partial-onset seizures with or without secondarily generalized seizures.
Eric Pina-Garza, MD
The FDA recently expanded the indication of Eisai Inc.’s antiepileptic drug perampanel (FYCOMPA) for monotherapy and adjunctive use in pediatrics 4 years of age and older for treatment of partial-onset seizures with or without secondarily generalized seizures.
There is an unmet need for new treatment options for this patient population, as many patients that despite treatment continue to persist with seizures and/or side effects.
To provide additional insight on FYCOMPA and the importance of its approval, NeurologyLive spoke with Eric Pina-Garza, MD, pediatric neurologist at Tri-Star Medical Group Children’s Specialists, in an interview. Pina-Garza noted that one of the benefits of FYCOMPA is that both patients and parents now have a once-daily dosing option with a longer half-life.
Eric Pina-Garza, MD: I think this is a very welcome addition for people that treat epilepsy because it gives us a good option. We have an unmet need, so we have about 25 drugs that we can use to treat epilepsy, many of them with similar mechanisms of action, but we still have a large population of patients that despite these treatments continue to have seizures or side effects or both, so having a new option with a good profile is a very good additional to try and help these kids.
One of the biggest advantages in the newer treatments in epilepsy has been the development of drugs that you can take once a day—sometimes people don’t understand that that’s huge, because the more you have to remember something, the more you forget it. There is evidence that when you take medications once a day you may miss about 10% of the doses, twice a day more like 20%, and 3 times a day more than 30%, so clearly if you’re not able to take it, it’s hard for the medication to work.
For perampaneal (FYCOMPA) one additional, and I’ll say potential benefit, is that we have several drugs that are once a day, but FYCOMPA is once a day because of its long half-life, and what that means to me is that the medication can be given once a day and if you’re late or even if you miss a dose, as we know many times happens, your levels don’t drop significantly during that time. They drop some, but not as much as with medications that have short half-life.
EPG: Yes, a couple of things. The first is that this is a drug with a new mechanism of action, so for the cases this drug can be used as monotherapy for the patients and we have to use polypharmacy, there will always be a national polypharmacy because there is nothing on the market that has the same mechanism of action.
That makes a lot of sense treating diseases that are hard to control, the condition that most people are familiar with is hypertension and usually when you have hypertension you might try a beta blocker and if that is not enough, you don’t add another beta blocker, you try to use a diuretic or a calcium channel blocker.
It’s the same in epilepsy, we have many patients that have failed drugs that work on the sodium channels and adding another sodium channel may not add significant benefits and it may add toxicity. Here again, adding a new mechanism of action helps to provide hopefully a better control.
The other one is that one of the most common requests from every patient I treat is the mothers saying, I don’t want you to make my child a zombie, and this comes from something in the past when we had a lot of patients experience bad side effects from medications. In fact, in the 1990s there was an anonymous survey, the Roper Poll that showed that even though 60% of patients with epilepsy were seizure free about 85% of them were unsatisfied possibly because of side effects.
Perampanel, FYCOMPA, one of the good things that I collaborated on with Dr. Meador, was that we found that the cognitive profile is good, so we didn’t see any negative traits compared to a sugar pill, basically not making people have negative effects upon completion. The main side effect from the medication can be behavioral side effects, but most of the time this was noted with a high dose of fast titration. In fact, the earlier doses that proved to be effective, up to 4 milligrams, the incident of this adverse event was less than the sugar pill. We have a drug that has a very favorable profile.
EPG: FYCOMPA was initially approved for adjunctive use in partial-onset seizures (POS) in 2012 and was later approved as adjunctive therapy for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older, and then as monotherapy for POS with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. To date, FYCOMPA is approved in 55 countries and has treated more than 200,000 patients worldwide across all indications. It’s been approved mainly for adolescents and adults for treatment of partial epilepsy both in monotherapy and adjunctive, and for treatment of generalized epilepsy, generalized tonic-clonic seizures, as an adjunctive treatment.
Having FYCOMPA approved for kids is important for several reasons. One, to have the blessing of the FDA that looks very carefully about safety and efficacy on kids. Two, having that label allows for us to have third payers acknowledge and approve the drugs. In the past, many times it’s a huge obstacle even if you thought it was a good option to try to get it approved for a child if the FDA has not gotten that indication.
The more information we can get out for people to treat epilepsy better, the best I feel!
Transcript edited for clarity.