The U.S. Food and Drug Administration (FDA) has approved a new drug, called Rizaport, for the treatment of acute migraine in adults. Rizaport is a fast-dissolving oral tablet that contains the active ingredient rizatriptan, which belongs to a class of drugs called triptans.

Migraine is a neurological condition that affects approximately 39 million people in the United States. It is characterized by recurrent episodes of moderate to severe headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. Triptans are a commonly used class of drugs for the treatment of acute migraine, but they are not effective for all patients and may cause side effects such as dizziness and fatigue.

Rizaport, developed by Intec Pharma, offers a new option for the treatment of acute migraine. It is designed to dissolve rapidly on the tongue, allowing for faster onset of action compared to traditional tablet formulations. In addition, because it is absorbed through the oral mucosa rather than the digestive system, it may be less likely to cause gastrointestinal side effects.

The FDA's approval of Rizaport was based on the results of a clinical trial that involved over 1,000 patients with migraine. The trial showed that Rizaport was more effective than placebo in relieving migraine pain at two hours post-dose. In addition, Rizaport was found to be well-tolerated by patients, with a safety profile similar to that of other triptans.

"We are pleased to announce the approval of Rizaport, which represents an important advance in the treatment of migraine," said Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research. "The fast-dissolving formulation of Rizaport provides patients with a new option for the treatment of acute migraine that may offer faster relief and a potentially lower risk of gastrointestinal side effects."

The approval of Rizaport is expected to have a significant impact on the treatment of migraine, as it provides patients with a new option that is both fast-acting and well-tolerated. In addition, the fast-dissolving formulation may be particularly beneficial for patients who have difficulty swallowing traditional tablet formulations.

"Rizaport represents a significant advance in the treatment of migraine," said David Dodick, MD, president of the International Headache Society. "The rapid onset of action and favorable safety profile make it a promising option for patients who suffer from this debilitating condition."

In conclusion, the FDA's approval of Rizaport represents an important advance in the treatment of acute migraine. This new fast-dissolving formulation of rizatriptan offers patients a new option that may provide faster relief and a potentially lower risk of gastrointestinal side effects. This is a significant development in the fight against migraine, which affects millions of people worldwide.

https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-treat-migraine