Akums Drugs and Pharmaceuticals Ltd., a Contract Development and Manufacturing Organization (CDMO), has announced the launch of Doxylamine + Pyridoxine extended-release tablets, a therapy approved by the CSDCO (Central Drugs Standard Control Organization), India and the United States Food and Drug Administration (USFDA). This marks a milestone as a therapy in India, with a [patent application in process]. Akums’ inventive solution aims to tackle the issues by integrating Doxylamine and Pyridoxine into extended-release tablets.

Doxylamine, a competitive histamine H1 receptor inhibitor with sedative and anticholinergic effects, is paired with Pyridoxine Hydrochloride (Vitamin B6), known for its anti-emetic properties and its role in haemoglobin production and neurotransmitter metabolism. This combination aims to offer an effective tool to manage symptoms of nausea and vomiting during pregnancy, ensuring better outcomes for both mothers and infants.

Sanjeev Jain, Joint Managing Director, Akums Drugs & Pharmaceuticals Ltd., said “During the initial trimester of pregnancy, many women grapple with the challenges of nausea and vomiting, commonly known as morning sickness. Despite its misleading name, morning sickness is not confined to a specific time and can occur day or night. While it may be unpleasant, it is generally considered a normal facet of a healthy pregnancy. In more severe instances, referred to medically as hyperemesis gravidarum, the intensity of nausea and vomiting reaches a point where a pregnant woman experiences frequent daily episodes, weight loss, and faces dehydration or is at risk of dehydration. Left untreated, this rare pregnancy-related condition can pose risks to both the woman’s health and her baby. In response to this critical issue, Akums has introduced this innovative solution. We have combined Doxylamine and Pyridoxine to improve the efficiency of treatment. Through this combination therapy, we aim to empower mothers to navigate a smoother and healthier pregnancy journey.”

Adding further, Sandeep Jain, Joint Managing Director, Akums Drugs & Pharmaceuticals Ltd., noted, “This is yet another innovative product developed by our R&D team. With Akums’ pioneering Doxylamine and Pyridoxine tablets, women experiencing severe morning sickness now have the opportunity to ease their symptoms and prevent further discomfort. This innovative therapy is specifically indicated for pregnant women who do not respond to conservative management, making it a much-needed solution for a challenging condition. Additionally, incorporating lifestyle changes as suggested by Doctor can contribute to easing nausea and vomiting, ultimately enhancing the overall pregnancy experience.”