Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Onzetra Xsail

Intranasal delivery of migraine medication

Publish date:: February 9, 2016

Avanir Pharmaceuticals, Inc. announced that FDA has approved Onzetra Xsail (sumatriptan nasal powder), formerly known as AVP-825. Onzetra Xsail is an intranasal medication delivery system consisting of a low-dose (22mg) of sumatriptan powder that is delivered utilizing the novel Xsail Breath Powered Delivery Device. Onzetra Xsail is a fast-acting dry powder formulation of sumatriptan, the most commonly prescribed migraine medication.

Indication: Onzetra Xsail is indicated for the acute treatment of migraine with or without aura in adults.

Adverse reactions: In clinical trials, the most common adverse reactions (≥ 2% and > placebo) were abnormal taste, nasal discomfort, rhinorrhea, and rhinitis.

Citation: Avanir Pharmaceuticals announces FDA approval of ONZETRA Xsail (AVP-825) for the acute treatment of migraine in adults. [news release]. Aliso Viejo, CA: Avanir Pharmaceuticals, Inc.; January 28, 2016. http://www.avanir.com/press/avanir-pharmaceuticals-announces-fda-approval-onzetra%E2%84%A2-xsail%E2%84%A2-avp-825-acute-treatment-migraine. Accessed January 29, 2016.

This Week's Must Reads

COVID-19 vaccine found effective but doctors watching for reactions, adverse events,

Study links sleep meds and dementia risk in older adults,

Childhood Hodgkin survivors have neurocognitive impairment,

Obesity, hypoxia predict severity in children with COVID-19,

Long-term safety and efficacy of teriflunomide for relapsing MS,

Must Reads in FDA Actions

FDA Approves Inbrija for PD OFF Episodes, Acorda Therapeutics news release; 2018 Dec 21

FDA Approves Firdapse for Rare Autoimmune Disorder, FDA news release; 2018 Nov 28

FDA Approves Ajovy for Migraine in Adults, Teva Pharmaceutical news release; 2018 Sep 14

FDA Approves Tiglutik for Treatment of ALS, ITF Pharma news release; 2018 Sep 6

FDA Approves Diacomit for Treatment of Seizures, Biocodex news release; 2018 Aug 23