Impel NeuroPharma wins new perspective on providing old migraine drugs FDA approved On Friday, provide patients with a faster way to respond to debilitating migraine attacks.
Impel product Trudhesa is a nasal spray for the migraine drug dihydroergotamine mesylate (DHE). The regulatory decision covers the acute treatment of migraine in adults, with or without aura.
For decades, DHE has been used as a treatment for migraine headaches, administered in the form of injections, infusions, or nasal sprays. But injections and infusions must be performed by doctors in medical institutions. Although patients can apply nasal spray by themselves, these doses may not provide enough medicine. Triptans are the most commonly prescribed drugs for the treatment of acute migraine, and they provide patients with a choice of pills. But Impel points out that research shows that these drugs must be taken early in the onset of migraines, and it may take several hours for patients to feel their effects.
Impel’s proprietary precision olfactory transmission (POD) technology is designed to deliver DHE to the upper nasal cavity, which is rich in blood vessels and can absorb drugs quickly. This method is designed to allow the drug to enter the blood quickly without requiring the patient to use a needle.In addition, the drug can be taken at any time during a migraine attack
The FDA’s decision is based on the results of an open-label Phase 3 study that recruited 360 people who suffered at least two migraine attacks per month. Instruct patients how to self-administer and record their migraine in a diary. The study evaluated patients for 24 weeks; some participants were followed for another 28 weeks. The main goal is to measure the number of serious adverse events during the study.
Impel said that in the two clinical trials, more than 5,650 migraine attacks were treated. Impel reported 7 serious adverse events in 5 patients (1.4%) within 52 weeks. These events are not related to the nasal cavity, and clinical trial researchers believe that these events are not related to Trudhesa. The characteristics of treatment-related adverse events are mild and transient, including nasal congestion, nausea, nasal discomfort, and unpleasant taste. Impel started a 12-month extension study to collect more data on long-term use of the drug, but since no safety issues were observed in the 6-month group, the study was ultimately deemed unnecessary.
Although no safety signals have been observed in clinical trials, Trudhesa’s label has a black box warning to remind doctors and patients that the drug should not be taken with drugs (or foods, such as grapefruit) that contain CYP3A4 inhibitors. Dangerous drug interactions can increase the level of DHE in the blood, which may lead to narrowing or blockage of peripheral arteries, thereby restricting the distribution of blood to the extremities.
In order to obtain FDA approval for Trudhesa, Impel will enter the market before Satsuma Pharmaceutical. The San Francisco-based company is developing a drug-device combination product that can also manage DHE. But Summer suffered setbacks after failing treatment in the Phase 3 test last year. After analyzing the clinical trial data, Summer made minor modifications to its equipment and formulated a new key research plan, Currently in progress.
Impel went public in April and raised US$80 million Because the company is preparing to commercialize its first migraine POD product. The company’s pipeline includes POD candidates for autism spectrum disorders and Parkinson’s disease.
Impel is expected to launch Trudhesa next month. The company plans to discuss Trudhesa’s approval during a conference call on September 7 at 8:30 a.m. Eastern time.
Photo courtesy of Impel Neuropharma
