For patients who prefer non-oral drugs or cannot tolerate tablets, the nasal spray formulation of sumatriptan has offered an appealing solution without the pain of injections. Both poor absorption and side effects have kept this delivery system for the mainstay migraine drug from fulfilling its promise to date. A recent report in CNS Drugs indicates that a new formulation has resolved those issues and given the 10 mg nasal spray pharmacokinetics similar to the subcutaneous version.
The new formulation, DFN-02, includes a permeation enhancer (0.20% 1-O-n-dodecyl-β-d-maltopyranoside or DDM) with sumatriptan. DDM reduces mucosal viscosity in the nose and enables the drug to cross the nasal epithelium more easily.
Woman using nasal spray. Source: Getty
Researchers led by Richard B. Lipton, MD, of the Albert Einstein College of Medicine in New York, tested the new formulation, DFN-02, in a multicenter, randomized, double-blind, placebo-controlled efficacy and safety study. The study had two double-blind treatment periods.
They randomized 107 adult participants to receive either placebo or DFN-02. All patients had at least a one year history of two to eight attacks per month with not more than 14 headaches each month and intervals of at least 48 hours between headaches. Participants entered migraine and medication data into an electronic diary during the study.
In the first study period, patients were instructed to use the assigned nasal spray within an hour of first experiencing moderate to severe migraine pain. They could take a second dose of the study medication or rescue medication if the first dose did not provide relief within two hours.
In the second period, researchers re-randomized those participants who had experienced and treated a migraine and recorded their response to the medication in the electronic diary and instructed patients to treat the next migraine of any intensity.
Patient history indicated that 34.4% of participants experienced significant relief with their usual migraine medication, while 34.4% had slight reduction in symptoms and 26.9% enjoyed complete relief and 4.3% experienced no relief from symptoms. Forty-three percent had complete or significant relief within two hours of treatment and 62.4% used either ibuprofen or a caffeinated analgesic combination. Less than 12% used sumatriptan on a regular basis.
Among patients who used DFN-02, 83.3% had mild or no functional disability at two hours post-treatment and 56.3% were totally free from disability at that point. That represented a notable improvement in the response seen previously to the commercial formulation of 20 mg sumatriptan, which about 70% of patients said left them with mild to no functional disability after two hours.
Between 70% and 78% of patients treated with DFN-02 reported satisfaction with the treatment and most said they were significantly more satisfied with DFN-02 than with their usual medication or placebo at two hours and 24 hours after treatment.
The new formulation also showed a significantly lower rate of adverse events, dropping for 38% in two prior studies to 9.7% in the current study. No patients reported nausea with DFN-02 compared to 19% of those who used the commercial formula in early trials. Dysgeusia, which affects up to 27% of users of the commercial formulation of the nasal spray, occurred in 2% to 8.1% of participants in this study.