FDA officials have approved a nasal spray of dihydroergotamine mesylate (Trudhesa; Impel NeuroPharma) for the acute treatment of migraine with or without aura in adults.
The spray provides proven and well-established therapeutic dihydroergotamine mesylate to the bloodstream through the vascular-rich upper nasal space. According to a press release, the spray skips the gut and the possible absorption problems associated with it, offering quick, sustained and consistent relief of symptoms. This relief is consistent even when the drug is administered hours after the onset of a migraine.
According to the press release, the company plans to launch the nasal spray in early October 2021.
“We are delighted with Trudhesa’s approval and are proud to offer millions of migraine Americans an acute non-oral treatment option that can provide quick, sustained and consistent relief, even when taken late in an attack. of migraine, ”he said. Adrian Adams, President and CEO of Impel NeuroPharma, in the press release.
Approval is based on the results of the STOP 301 phase 3, open-label, pivotal trial, which included more than 5,650 migraine attacks treated for 24 or 52 weeks. The primary objective was to evaluate the safety and tolerability of mesylated dihydroergotamine nasal spray and exploratory objectives, including efficacy evaluations and a patient acceptability questionnaire.
The results showed that nasal spray was generally well tolerated and provided rapid, sustained, and consistent relief of symptoms. Unlike some acute oral treatments that must be taken within an hour after the onset of migraine, the trial found that Trudhesa was consistently effective even when taken late in an attack of migraine. migraine.
“Many of my patients need more of their migraine treatment and Trudhesa offers a reliable, non-oral, fast-acting option that outweighs many current medication challenges,” said Stephanie J. Nahas-Geiger, MD, MSEd , director of the Headache Medicine Scholarship Program at Thomas Jefferson University, in the press release. “His upper nose evades the [gastrointestinal] common treatments and phenomena associated with migraine, such as nausea and gastroparesis, which may affect the effectiveness of oral treatments ”.
In the STOP 301 trial, there were no drug-related treatment-related adverse events (ASDs) and most ASDs were mild and transient in nature. Some of the most frequently reported adverse events during the 52-week study period were nasal congestion, nausea, nasal discomfort, abnormal olfactory tests, and vomiting.
Patient-reported exploratory efficacy findings showed that 38% of patients had freedom from pain, 66% had pain relief, and 52% had freedom from the most annoying migraine symptoms 2 hours after the first dose of Trudhesa . In addition, 16% of patients said pain relief began just 15 minutes after the first dose.
Of those who had no pain at two hours, 93% still had no pain at 24 hours and 86% still had no pain at two days. The majority (84%) of patients reported that nasal spray was easy to use and said they preferred their current therapy.
“Migraine is a disease that affects the whole body and is the second leading cause of disability,” Kevin Lenaburg, executive director of the Coalition for Headaches and Migraine Patients, said in the press release. “Historically there have not been enough effective treatments to treat migraine attacks, especially treatments that are not oral medications, which can be difficult due to nausea, vomiting and others. [gastrointestinal] symptoms that may appear during a migraine “.
REFERENCE
Impel NeuroPharma announces US FDA approval of nasal spray Trudhesa (dihydroergotamine meshydrate) for the acute treatment of migraine. Press release. Impel NeuroPharma; September 3, 2021. Accessed September 3, 2021. https://impelnp.com/2021/09/03/impel-neuropharma-announces-us-fda-approval-of-trudhesa-dihydroergotamine-mesylate-nasal- spray-for-acute-migraine-treatment /