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Business Standard

Akums secures patent for dual-action nausea drug for pregnant women

Akums Drugs & Pharmaceuticals has received a patent for its extended-release combination formulation of Doxylamine and Pyridoxine, developed to manage nausea and vomiting in pregnancy (NVP). The formulation, using the company's proprietary 'tablet-in-tablet' technology, has been approved by the Drug Controller General of India (DCGI). NVP affects up to 80 per cent of pregnant women, with around 20 per cent experiencing symptoms throughout their pregnancy. The condition can impact nutrition, daily activity, and overall well-being. Akums' patented formulation combines immediate and sustained drug release in a single tablet, aimed at providing extended symptom relief and reducing dosing frequency. The outer layer of the tablet is designed for rapid onset, while the inner core provides a longer therapeutic effect. This dual-action mechanism is intended to improve dosing convenience and adherence. Commenting on the approval, Sanjeev Jain, Managing Director, Akums, said: 'This new formulation for managing nausea and vomiting during pregnancy ensures access to safe and effective care during a critical phase of life. With this, we are making life a little easier for expectant mothers and helping healthcare move closer to where it should be — accessible, reliable, and full of care.' The formulation has undergone a bioequivalence study. While subject numbers remain confidential as per regulatory norms, the data submitted was deemed sufficient for DCGI approval. Akums says the combination is positioned to address a treatment gap in pregnancy care by offering longer-lasting symptom control. Akums is a contract development and manufacturing organisation (CDMO) with 12 manufacturing units, four R&D centres, and more than 16,000 employees. It reports over 4,100 commercialised formulations and 220 products under development. The company's product pipeline spans multiple dosage forms and therapeutic categories. This development adds to Akums' existing portfolio of drug delivery innovations aimed at both domestic and export pharmaceutical markets.