DFN-02 nasal spray may be effective, well tolerated, and safe for the acute treatment of episodic migraine, according to results published in Headache.
DFN-02 is a nasal spray comprised of sumatriptan 10 mg plus a permeation-enhancing excipient (0.2% 1-O-n-Dodecyl-b-D-Maltopyranoside).
The multicenter double-blind phase 2 study (Clinicaltrials.gov identifier: NCT02856802) included 93 individuals with at least a 12-month history of episodic migraine who had an average of 2 to 8 episodes per month with no more than 14 headache days per month and a minimum of 48 headache-free hours between attacks. Participants were randomly assigned to receive DFN-02 (n=50) or placebo (n=43) and were instructed to treat a single migraine attack of moderate to severe pain intensity. The study’s primary end point was the percentage of participants who were pain free at 2 hours postdose. Secondary end points included pain relief, absence of the most bothersome symptom, and freedom from nausea, photophobia, and phonophobia.
The proportion of participants who were free from headache pain at 2 hours postdose was greater in the DFN-02 group (21/48; 43.8%) compared with the placebo group (9/40; 22.5%; P =.044). The percentage of participants who had pain relief at 2 hours was also higher in the DFN-02 vs placebo group (83.3% vs 55.0%, respectively; P =.005). Compared with the placebo group, more participants in the DFN-02 group were free from their most bothersome symptom (70.7% vs 39.5%, respectively; P =.007), from nausea (78.3% vs 42.1%, respectively; P =.026), from photophobia (71.8% vs 38.9%, respectively; P =.005), and from phonophobia (78.1% vs 40.0%, respectively; P =.004).
Adverse events were reported in 9 of 93 participants (9.7%). The most common treatment-emergent adverse event associated with DFN-02 was dysgeusia.
“These initial results are promising, but the appropriate place of DFN-02 in the migraine therapeutic armamentarium will ultimately be determined by outcomes in future clinical trials and, once approved for use, in real-world treatment settings,” the researchers wrote.
Lipton RB, Munjal S, Brand-Schieber E, Rapoport AM. DFN-02 (sumatriptan 10 mg with a permeation enhancer) nasal spray vs placebo in the acute treatment of migraine: a double-blind, placebo-controlled study. Headache. 2018;58:676-687.