A New FDA Drug Approval: low-dose sumatriptan powder

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A New FDA Drug Approval: low-dose sumatriptan powder

The Food and Drug Administration (FDA) has recently approved a low-dose Sumatriptan powder delivered intranasally for the treatment of migraine with or without aura, in adult patients. It is a nasal powder but is not sprayed or inhaled through the nostrils. It uses the breath-powered delivery device, which delivers a low dose into the nose.

Sumatriptan powder is a fast-acting dry powder formulation of sumatriptan, the most commonly prescribed migraine medication. However, there are so many migraine treatments are available in the market, but none of them offers satisfactory and reliable benefits.  This new drug provides a new and much-needed treatment option for this debilitating condition affecting milllions of people across the world. However, because of inconsistent effectiveness due to delayed absorption, it requires a higher dose to attain desired bioavailability.

The FDA approval was based on data from double-blinded, multi-centered, placebo-controlled, parallel-group study. In this study, participants received Sumatriptan powder, 22 mg or placebo in an attempt to treat moderate to severe migraine episodes. Pain scores were assessed at various points of time after drug administration. In the Sumatriptan powder group, statistically significant reduction in headache intensity 2 hours post-treatment was observed (67.6% vs. 45.2%, p=0.002). The average time to attain significant significant pain relief in patients treated with Sumatriptan powder was 47 minutes (approx.); 19.4% of study participants experienced relief in 15 minutes. Significant differences favoring Sumatriptan powder in maintenance of relief at 24 and 48 hours post-administration were demonstrated.

Sumatriptan powder was well tolerated with a low incidence of side effects. Safety and efficacy of this drug was not studied in patients with cluster headaches or in patients <18 years of age. Nursing mothers should avoid breastfeeding for 12 hours post-treatment. Triptans are contraindicated in ischemic/vasospastic coronary artery disease, arrhythmias, Wolff-Parkinson-White syndrome, stroke/ transient ischemic attack, peripheral vascular disease, ischemic bowel disease, uncontrolled hypertension, severe hepatic impairment, and hypersensitivity reaction. Precaution must be taken in patients with increased risk of seizures. The drug carries a warning for overuse in headache and serotonin syndrome, especially with concomitant use of other medications affecting serotonin.

The recommended dose for Sumatriptan powder is 22 mg (11 mg nosepiece in each nostril). Its second dose of 22 mg may be administered at least 2 hours after the first dose. However, second dose should be taken only after physicians consultation. Maximum daily dose of this drug is 44 m or one Sumatriptan powder and another sumatriptan product separated by 2 hours.

Source:

FDA

Link to the source:

http://drugtopics.modernmedicine.com/drug-topics/news/new-dosage-form-migraine-treatment

Original title of article:

New dosage form for migraine treatment

FDA
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