A new nasal spray from Pfizer has just been OKed by the Food and Drug Administration, and the company hopes it will be a game changer for the nearly 40 million migraine sufferers in the US. Reuters reports on the FDA's Friday approval of zavegepant, sold under the brand name Zavzpret, for migraines with and without aura after a late-stage study showed the drug performed very well compared with a placebo. One of its apparent benefits: how fast it takes effect, with the study showing pain relief as soon as 15 to 30 minutes after using the spray, and a return to normal activities shortly thereafter. Of the 1,400-plus subjects who took part in the study between October 2020 and August 2021, nearly a quarter of those who used Zavzpret reported being symptom-free after two hours, compared with 15% of placebo takers.
The drug also showed more efficacy than a placebo at treating symptoms of a migraine—defined as at least five bouts of headache lasting four to 72 hours, according to the National Headache Foundation—up to 48 hours later. Zavegepant falls under a class of drugs called calcitonin gene-related peptide inhibitors, and treatments are already available from such companies as AbbVie, Eli Lilly, Teva Pharmaceuticals, and Amgen. Pfizer is hoping its entry will beat the rest on speed. "Fifteen minutes is very quick, even for other nasal sprays," Dr. Kate Mullin of the New England Institute for Neurology & Headache, who also served as the lead investigator during the zavegepant trial, tells USA Today.
Angela Hwang, Pfizer's chief commercial officer and president of its global pharma business, calls zavegepant a "significant breakthrough for people with migraine who need freedom from pain and prefer alternative options to oral medications," per a release. Mullin notes that those alternatives come in especially handy when migraine sufferers can't take meds orally due to migraine-induced nausea and vomiting. The release notes zavegepant "was well tolerated" during its clinical trials, with common side effects after using the nasal spray including a bad taste, nasal discomfort, and nausea. Some patients with a hypersensitivity to the drug reported hives and facial swelling. Zavzpret's price, "expected to be comparable in price to other FDA-approved migraine medicines," according to Pfizer, will be announced at the drug's launch in July, reports Reuters. (Read more migraines stories.)