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ZavzpretTM nasal spray for migraine gets FDA approval

ZavzpretTM (zavegepant) nasal spray, a calcitonin gene-related peptide (CGRP) receptor antagonist, has been authorised by the Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura in adults. The approval was based on results from two double-blind, placebo-controlled trials that assessed the effectiveness and safety of the nasal spray in people with a 1-year history of migraine (with or without aura) and migraine episodes lasting 4 to 72 hours on average if untreated. At 2 hours, therapy was significantly better than a placebo in terms of pain relief and independence from the most troublesome symptoms (nausea, photophobia, and phonophobia). The nasal spray was also shown to be statistically substantially better than a placebo for the additional effectiveness objectives in the pivotal phase 3 research (pain relief, return to normal function, sustained pain freedom, and phonophobia and photophobia freedom at 2 hours post-dose). Taste disturbances, nausea, nasal pain, and vomiting were the most common adverse effects reported with the nasal spray.

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