The long wait for a new formulation of migraine drug dihydroergotamine is over. Having rejected three filings from MAP Pharmaceuticals and Allergan in years gone by, the FDA gave the green light to Impel NeuroPharma late last week.
Novartis won approval for a dihydroergotamine nasal spray, now sold by Bausch Health, in the 1990s, but efforts to improve on the incumbent have been dogged by problems. MAP and Allergan finally gave up on their candidate after the FDA issued three rejections over manufacturing and delivery problems, and other companies such as Satsuma Pharmaceuticals have stumbled in the clinic.
Impel won FDA approval via the 505(b)(2) pathway on the strength of a phase 3 trial of 360 migraine patients that was primarily designed to assess safety and tolerability. Exploratory efficacy endpoints showed two-thirds of subjects experienced pain relief, and half had freedom from their key symptom two hours after a dose of the drug.
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Having won approval, Impel is now planning to launch the nasal spray early next month. Impel’s pitch for the market rests on claims that the product, which will be sold as Trudhesa, can be used at any time in a migraine attack. Some existing oral treatments need to be taken in the first hour of an attack to deliver maximum effect.
The effects of Trudhesa are tied to its delivery system. Impel has designed the metered dose device to get the active ingredient into the upper nasal space. Based on evidence the vasculature is more permeable than in the more commonly targeted lower nasal cavity, Impel thinks its targeting of the upper nasal space can yield more consistent dosing and uptake, improved efficacy and faster onset of action.