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Migraine Nasal Spray With Novel Delivery System Gains FDA Approval
Trudhesa became the second nasal spray option to use well-established medication for fast-acting migraine relief. By Don RaufSeptember 20, 2021Everyday Health ArchiveFact-CheckedThe commercial launch of Trudhesa is planned for early October.Impel NeuroPharmaThe U.S. Food and Drug Administration (FDA) this month approved a new nasal spray therapy for acute treatment of migraine. In a press release, the biopharmaceutical company Impel NeuroPharma announced that its product (called Trudhesa) uses a unique patented device called POD (Precision Olfactory Delivery) to administer dihydroergotamine mesylate (DHE) to the vascular-rich upper nasal cavity. The therapeutic device was found to provide well-tolerated, rapid, sustained, and consistent symptom relief. The medication itself is not the unique aspect of the product. DHE, which was approved for the treatment of migraine in 1946, has become a well-established short-term treatment of migraine and other vascular headaches such as cluster headache, according to the National Headache Foundation. The medication is also given for status migraine (a prolonged and severe attack lasting multiple days). Robert Cowan, MD, a headache specialist and a clinical professor of neurology at Stanford University in Palo Alto, California, stresses that an intravenous formulation of DHE is generally regarded as the gold-standard for breaking a status migraine that has gone on for greater than 72 hours and has not responded to the usual acute treatments such as triptans, NSAIDs (nonsteroidal anti-inflammatory drugs such as ibuprofen), and antinauseants. “DHE is not nearly as effective when delivered IM [intramuscularly via injection] or intranasally, although both delivery systems have been available for a number of years,” says Dr. Cowan. A nasal spray version of DHE marketed as Migranal received FDA clearance in 1997. What distinguishes Trudhesa is the POD system, which touts targeted delivery to the upper nasal cavity in order to hasten drug uptake. “Its upper nasal delivery circumvents the GI tract and common phenomena associated with migraine, such as nausea and gastroparesis, that can impact the effectiveness of oral treatments,” said Stephanie J. Nahas-Geiger, MD, an associate professor of neurology and the director of the headache medicine fellowship program at Thomas Jefferson University in Philadelphia in a comment included in the press release. “And, importantly, it is a self-administered, single dose that can be taken anytime during a migraine attack.” Amaal J. Starling, MD, an associate professor of neurology at the Mayo Clinic in Scottsdale, Arizona, says that for some patients, the new Trudhesa technology may offer certain advantages over Migranal. “The currently available DHE nasal spray is delivered to the nasal vestibule versus the new DHE nasal spray, which delivers DHE to the upper nasal space in efforts to reach higher bioavailability [the rate at which the drug is absorbed in the body] and increase tolerability by reducing spillage and adverse taste,” says Dr. Starling. On the other hand, Cowan expressed some skepticism about the new product being a game changer, saying that already “there are devices on the market that can deliver any drug into the upper nasal cavity.” “Could patients benefit from an effective and well-tolerated, affordable alternative to triptans and NSAIDs? Absolutely. Is this it? I think we need a lot more data to make that determination,” says Cowan. The commercial launch of Trudhesa is planned for early October. NEWSLETTERS Sign up for our Chronic Pain Newsletter
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