(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication to treat seizures linked to Dravet syndrome.
This drug is found under the name Fintepla (fenfluramine). The FDA approved it for use in patients 2 years old and older.
Dravet syndrome is a rare and chronic type of epilepsy. This syndrome is typically known to cause severe and persistent seizures, despite treatment with medications. It is classified as life-threatening.
Fintepla is available in solution form to be taken by mouth with or without food. This drug is a Schedule IV controlled substance.
“Dravet syndrome is a debilitating disease that takes a tremendous toll on both patients and their families,” said Dr. Billy Dunn, director of the FDA's Office of Neuroscience, in a press release. “Fintepla offers an additional effective treatment option for the treatment of seizures associated with Dravet syndrome. The FDA will continue to work with companies on drug development for Dravet syndrome and other types of epilepsy.”
Two clinical studies demonstrated the safety and the effectiveness of this medication, the FDA noted. Those who were given fenfluramine had significant reductions in the frequency of seizures during treatment.
Common side effects of fenfluramine may include (but are not limited to) constipation/diarrhea, decreased appetite, drooling, feeling extremely sleepy, feeling tired, fever, lack of coordination or balance, increased blood pressure and vomiting.
This medication comes with a boxed warning, which is the strongest type of warning, for the risk of problems with the valves in the heart (valvular heart disease) and high blood pressure in the arteries of the lungs (pulmonary arterial hypertension).
As a result, your doctor will monitor your heart with echocardiograms before treatment and every six months during treatment. The doctor will also monitor your heart one time three to six months after you stop treatment.
The FDA granted approval of this medication to Zogenix, Inc.