In a significant breakthrough for maternal healthcare, Akums Drugs & Pharmaceuticals has been granted a patent for its extended-release combination formulation of Doxylamine and Pyridoxine, developed to manage nausea and vomiting in pregnancy (NVP). The formulation, which utilizes Akums’ proprietary “tablet-in-tablet” technology, has recently received approval from the Drug Controller General of India (DCGI).
Addressing a Widespread Issue in Pregnancy Care
NVP can severely impact a woman’s nutrition, daily activities, and overall well-being, creating a need for effective treatments that address both the short-term and long-term needs of expectant mothers.
Akums’ innovative formulation provides an effective solution to this problem by combining the benefits of immediate and extended drug release in a single tablet. This novel combination is designed to offer prolonged symptom relief and reduce the frequency of dosing, improving patient adherence to the treatment regimen.
Dual-Action Mechanism for Improved Convenience
The tablet-in-tablet technology developed by Akums is a significant advancement in drug delivery. The formulation consists of two layers: an outer layer that provides a rapid onset of action to quickly alleviate the symptoms of nausea, and an inner core that ensures a longer therapeutic effect. This dual-action mechanism aims to enhance the convenience of treatment by reducing the need for frequent dosing and improving overall symptom management.
The company believes that this formulation will offer better symptom control for expectant mothers, allowing them to manage NVP more effectively and comfortably throughout their pregnancy.
Key Approvals and Regulatory Considerations
The DCGI approval marks a pivotal moment in Akums’ journey to provide a solution for a widespread condition that affects many pregnant women. The formulation has already undergone a bioequivalence study, and while the specific number of subjects in the study remains confidential due to regulatory norms, Akums confirmed that the data submitted was sufficient for obtaining the DCGI’s approval.
The company emphasizes that the approval of this extended-release formulation provides a new treatment option for expectant mothers, addressing a significant gap in pregnancy care by offering long-lasting control of nausea and vomiting. Akums has designed the formulation with a focus on safety, efficacy, and patient adherence, ensuring that it can be a trusted part of pregnancy care routines.
The launch of this new formulation underscores Akums’ commitment to innovative drug delivery technologies and their ongoing efforts to address significant unmet needs in the pharmaceutical market. The company is known for its robust contract development and manufacturing organization (CDMO) services, and this latest development adds to its growing portfolio of drug delivery innovations.
Akums’ Expansive Operations and Product Portfolio
Akums operates with a large-scale infrastructure that includes 12 manufacturing units, four R&D centers, and over 16,000 employees. The company reports having successfully commercialized over 4,100 formulations and has more than 220 products under development across various therapeutic categories.
The approval of the Doxylamine and Pyridoxine combination formulation is part of Akums’ broader strategic initiative to enhance its presence in both domestic and export pharmaceutical markets. The company’s growing product pipeline spans a wide range of dosage forms and therapeutic areas, reflecting its ability to innovate in diverse segments of the pharmaceutical industry.
A Key Step in Pregnancy Care
This development is a step forward in addressing the challenges faced by pregnant women suffering from NVP. By offering an extended-release formulation, Akums has created a treatment that not only provides effective symptom control but also improves the convenience and adherence to medication, which is often a challenge for expectant mothers managing NVP.
The formulation is poised to meet the growing demand for more accessible and effective healthcare options for pregnant women. Akums’ focus on patient-centric innovation positions the company as a key player in improving maternal health outcomes, particularly in regions where access to modern treatments remains a challenge.
Looking Ahead
With the DCGI’s approval, Akums is now poised to roll out this extended-release Doxylamine and Pyridoxine formulation to a wide market, benefiting pregnant women across India and potentially beyond. As the company continues to expand its research and development efforts, it is likely to remain at the forefront of pharmaceutical innovation, developing new treatments that meet the evolving needs of patients in both domestic and international markets.
In summary, Akums’ patented formulation for nausea and vomiting in pregnancy represents a significant achievement in the realm of maternal health. By leveraging its proprietary drug delivery technology and addressing a critical gap in pregnancy care, Akums is setting new standards for how pharmaceutical companies can innovate to improve the quality of life for expectant mothers.