CDSCO panel nod to Bajaj Healthcare for Phase III clinical trials of insomnia drug Suvorexant
Mumbai: Bajaj Healthcare Limited has announced that it has received a positive recommendation from the Subject Expert Committee (SEC) (Neurology & Psychiatry) of the Central Drugs Standard Control Organisation (CDSCO) to initiate Phase III clinical trials for Suvorexant Tablets, available in strengths of 5mg, 10mg, 15mg, and 20mg.
Suvorexant is a prescription medication used to treat insomnia in adults. It works by modulating the sleep-wake cycle through the central nervous system, promoting improved sleep onset and maintenance. The upcoming Phase III trials will evaluate the efficacy, safety, and tolerability of Suvorexant in a diverse patient population, representing the final and most crucial step before regulatory submission.
Upon successful completion, Bajaj Healthcare intends to pursue marketing authorization in select markets, paving the way for its commercial launch.
Speaking at the occasion Anil Jain, Managing Director, Bajaj Healthcare Limited, said, “We are encouraged by the SEC’s recommendation and remain committed to advancing Suvorexant through the final stages of clinical development. With our robust R&D infrastructure and GMP-compliant manufacturing capabilities, we are confident in our ability to deliver high-quality, impactful CNS solutions to patients worldwide. This development not only strengthens our neurology portfolio but also aligns with our strategic vision of addressing unmet medical needs in chronic and lifestyle-related disorders.”
Bajaj Healthcare Limited a Manufacturer of APIs, Intermediates and Formulations. Established in the year 1993, it specializes in manufacturing of intermediates, API, formulations & Nutraceuticals. The Company has state-of-art manufacturing facilities of APIs, intermediates and formulations. These facilities are designed to meet the requirements of both advanced as well as emerging market opportunities. BHL has a strong presence globally in countries like Europe, USA, Australia, Middle East and South America.
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