Monday, November 12, 2018
Strides Pharma Science Limited (Strides) has announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte Limited, Singapore has entered into an exclusive product development, licensing and supply agreement with SUDA Pharmaceuticals Ltd for its novel drug SUD-0001H, an oral spray of sumatriptan to treat migraine headache for the US market.
Execution of Strides’ generic product pipeline for the US is nearing completion and is expected to have 150+ ANDA filings by 2021.The company is now focusing on developing a portfolio of complex and specialty products including products filed under the 505B (2)regulatory pathway. The company through inhouse development and partnerships will build a portfolio of limited competition products offering exclusivity for a sustainable period. Today's announcement of partnership with SUDA is part of company’s specialty portfolio buildout for the US market.
Sumatriptan is one of the most widely used drugs for the treatment of acute migraine in adults. SUD-001H is a first-in-class mint-flavoured oral spray formulation of sumatriptan (marketed in tablet form and in a nasal spray by GlaxoSmithKline under the brand name Imitrex). The product will be filed with the USFDA under the 505B (2) regulatory pathway and on approval is expected to be the first fast-acting oral spray of sumatriptan in the US market.The product will utilize SUDA’s recently developed proprietary OroMist hydrotrope technology that significantly improves the rate of absorption and the quantity of drug that is absorbed across the mucosal membranes. A primary market assessment on the potential for SUD-001H for the treatment of adult migraine confirmed the need for a product that could demonstrate a faster onset of action and the same was supported by medical practitioners.
