Akums launches extended-release tablets for severe morning sickness

Source: Financial Express

Akums Drugs and Pharmaceuticals Ltd., a Contract Development and Manufacturing Organization (CDMO), on Wednesday 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).

The company claims that 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, it claimed.

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.

“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,” Sanjeev Jain, Joint Managing Director, Akums Drugs & Pharmaceuticals Ltd., said.

The conventional Doxylamine + Pyridoxine available in the Indian market is equipped with an “enteric” coated delayed-release mechanism. This feature ensures that the tablets dissolve gradually in body fluids, potentially facilitating sustained release, consequently, a delayed onset of action. However, this delayed release may not align with the urgent therapeutic needs of addressing Nausea and Vomiting in pregnancy.

“In contrast, Akums introduces a more advanced solution with its Doxylamine 20 mg + Pyridoxine 20mg extended-release tablet. This formulation incorporates an immediate-release layer, allowing for a swift onset of action following ingestion. Simultaneously, the extended-release feature ensures prolonged and consistent relief from symptoms, catering to the specific demands of the disease condition. This innovative approach optimises both immediacy and sustainability, offering a more effective and comprehensive solution for managing Nausea and Vomiting in pregnancy, the company said in a statement.

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