Community Corner: Seizure Medicine News

New Drug Application for Valtoco^TM

People who have seizure clusters, bouts of seizure activity, or are at risk for seizure emergencies may have a new drug option soon. A New Drug Application (NDA) was filed with the U.S. Food and Drug Administration (FDA) recently by Neurelis for a diazepam nasal spray called Valtoco. This new drug is prepared in a Vitamin E solution that makes it easy to absorb and act quickly.

• The NDA for Valtoco requests approval for use in children 6 years and older, adolescents, and adults.
• The nasal spray is intended to be used outside of a medical setting by family members or caregivers.

New Indication for Fycompa^TM

A new indication for the use of Fycompa (perampanel) was recently approved by the FDA. This medication by Eisai is used to treat both focal and generalized onset seizures. This approval is another example of having medicines for children available faster. The data on Fycompa included its use in adults, as well as two, open labeled studies in children.

Fycompa is approved for

• Children as young as 4 years old who have focal onset seizures (with or without secondary generalization). It can be given alone or together with other seizure medications.
• Children who are 12 years and older who have with primary generalized tonic-clonic seizures can use Fycompa together with other seizure medicines.

Sympazan^TM Oral Film

A new form of clobazam, called Sympazan Oral Film made by Aquestive, received tentative approval by the FDA in August.

• It is intended to treat seizures associated with Lennox-Gastaut syndrome (LGS) in people 2 years of age and older.
• Clobazam is now available as Onfi oral tablets or liquids. Generic forms of clobazam may be available shortly.
• The Sympazan Oral Film offers a unique way of taking medicines - it can be placed on the tongue and is not swallowed. Sympazan will make taking clobazam easier for people who can’t swallow pills or liquids.

These updates offer exciting options for people with epilepsy that hopefully will help stop seizures and clusters in more people, be available to children as well as adults, and be easier to take.

Stay tuned for updates about these drugs and other epilepsy treatments!

Patty Osborne Shafer RN, MN