Posted from: Tuesday, December 11, 2018 - 04:45 PM - Present

Sympazan Approved to Treat Seizures

November 2, 2018 – The U.S. FDA has approved Sympazan™ (clobazam) oral film, manufactured by Aquestive Therapeutics, Inc., to provide adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients who are at least two years of age. It is the first and only oral film FDA-approved to treat seizures associated with LGS.

Although Sympazan’s active ingredient, clobazam, has been FDA-approved since 2011, it was previously only available in tablet or oral suspension, marketed under the brand name Onfi® and manufactured by Lundbeck. Sympazan carries the same indication as Onfi, but provides a new method of delivery for patients who have difficulty swallowing. Sympazan oral film, which melts in the mouth, is bioequivalent to clobazam tablets and has a comparable safety profile.

Lennox-Gastaut syndrome typically manifests in early childhood, and is one of the most difficult forms of epilepsy to treat. In clinical studies, clobazam has been shown to significantly reduce the frequency of drop seizures, which involve falls, compared to placebo.

Sympazan will be available in 5mg, 10mg, and 20mg berry-flavored dosages. Recommended dosing is based on weight. Patients should be started at the minimum dose for their weight, and titrated up as required and tolerated. Maximum dosing is 20mg per day for patients who weigh 30kg (66 pounds) or less, and 40mg per day for all other patients. Doses of 10mg or more should be divided in half and given separately.

According to a black box warning, the use of clobazam with opioids can cause profound sedation, respiratory depression, coma, and death. Concomitant prescribing of opioids with benzodiazepines like clobazam should be reserved for when alternative treatment options are inadequate, and the dose and duration should be limited to the minimum required. Patients prescribed both should be monitored for signs and symptoms of respiratory depression and sedation.

Aquestive Therapeutics has launched Sympazan at a wholesale acquisition cost (WAC) of $1,560 per month at a typical daily dose for patients who weigh at least 30kg.

Last Updated Friday, September 13, 2019 - 08:00 AM.