Tosymra, previously known as DFN-02, an intranasal spray containing sumatriptan (10 mg) and a 5-HT1B/1D receptor agonist developed by Dr. Reddy’s Laboratories Limited and its subsidiary Promius Pharma, LLC, is approved by the USFDA in January, 2019 for the acute migraine. In a multicenter, double blinded, randomized, placebo-controlled study, Tosymra was found to be safe, effective and well tolerated. As compared to the other sumatriptan products, Tosymra is contradicted in patients with a history of coronary artery disease or coronary artery vasospasm, Wolff-Parkinson-White Syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders, history of stroke, transient ischemic attack, or history of hemiplegic or basilar migraine because these patients are at a higher risk of stroke, peripheral vascular disease, ischemic bowel disease, uncontrolled hypertension, or severe hepatic impairment. The spray contains a permeation-enhancing excipient (Intravail), which allows the product to be quickly absorbed into the systemic circulation while demonstrating a similar pharmacokinetic profile as subcutaneous sumatriptan.
The report provides a comprehensive understanding of the drug, covering all the API manufactures and its details in the 7 major markets which includes EU5 (U.K., Spain, Germany, Italy and France), U.S., and Japan. It covers all patents and strategic developments reported in this drug area. It highlights the historical and forecasted sales along with the market scenario, market competition and the historical and emerging therapies. The report is inclusive of SWOT and PESTLE analysis, depending on the information availability.
Moreover, the report also provides a comprehensive understanding of the pipeline activities of the drug candidate under various stages of development, with detailed analysis of pipeline and clinical trials. Pipeline analysis of drug by phases includes product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology and others.