Novel Nasal Spray Safe, Effective for Episodic Migraines

The novel intranasal spray DFN-02 is safe and effective for use in patients with episodic migraines, according to a recent study.

DFN-02 is composed of 10 mg sumatriptan and a permeation-enhancing excipient. This composition allows sumatriptan to be absorbed quickly into the systemic circulation and demonstrate pharmacokinetics similar to subcutaneous sumatriptan.

To assess the safety and efficacy of DFN-02, the researchers assessed 173 adult participants with a diagnosis of episodic migraine with and without aura, based on the International Classification of Headache Disorders, 2nd edition. All participants in the study experienced 2 to 6 attacks per month with fewer than 15 headache days per month and 48 headache-free hours or more between each attack. Participants received DFN-02 for 6 months to acutely treat their migraine attacks.

A total of 167 (96.5%) participants had used at least 1 dose of DFN-02 and were evaluable for safety, and 134 (77.5%) subjects had completed the study. Results indicated that 2211 migraine attacks were reported, and 3292 doses of DFN-02 were administered. The mean monthly use of DFN-02 among participants was 3.6 doses.

Adverse events reported were those commonly associated with triptans and with nasally administered medications. The researchers observed no new safety signals. The most common adverse events over the study period were dysgeusia (21%) and application site pain (30.5%). Most adverse events related to the study drug were mild.

“DFN-02 was shown to be well tolerated when used over 6 months to treat episodic migraine acutely,” the researchers concluded.

—Christina Vogt

Reference:

Munjal S, Brand-Schieber E, Allenby K, Spierings ELH, Cady RK, Rapoport AM. A multicenter, open-label, long-term safety and tolerability study of DFN-02, an intranasal spray of sumatriptan 10 mg plus permeation enhancer DDM, for the acute treatment of episodic migraine. J Headache Pain. 2017;18(31). https://link.springer.com/article/10.1186/s10194-017-0740-3.