American pharma giant Abbott is planning to launch a modified version of a medication called dydrogesterone, for management of endometriosis-related pelvic pain. The company has also filed an application to seek permission to conduct a bioequivalence study and Phase-III clinical trials in India.
On May 18, Abbott submitted an application to the office of the Drugs Controller General of India (DCGI) – the apex health regulator – seeking permission for the manufacturing and marketing of “dydrogesterone modified release tablets 20 milligrams”, as per the new drugs and clinical trial rules.
Close to 2.5 crore Indian women suffer from endometriosis, which impacts their everyday lifestyle. Every four out of 100 women suffer from the painful disorder in which tissue similar to the uterine lining grows outside the uterus, in places including the abdomen and pelvic area.
At present, dydrogesterone tablets (10 mg) are available in India in “immediate release” (IR) format for the indications of progesterone deficiencies, such as the treatment of endometriosis, dysmenorrhoea and secondary amenorrhoea, irregular cycles and dysfunctional uterine bleeding. It is also used in the treatment of threatened miscarriage and habitual miscarriage apart from hormone replacement therapy.
Abbott India has not yet responded to an email sent to the company.
Company’s request to DCGI
“…We request you to kindly grant us permission in Form CT-06 and Form CT-07 to conduct a phase III clinical trial and bioequivalence study for Dydrogesterone Modified Release Tablets 20 mg followed by permission in Form CT-23 for manufacturing and marketing of Dydrogesterone Modified Release Tablets 20 mg,” stated the letter, which was accessed by News18.
The letter also requests the DCGI to include the firm’s proposal in the upcoming reproductive and urology subject expert committee (SEC) meeting, which is scheduled for May 25.
Manufacturing and clinical trial plan
The company proposes to manufacture the tweaked formulation at the Puducherry-based loan-licensed manufacturing site of Abbott India Ltd. In the clinical trial protocol, the company’s primary objective is to evaluate the efficacy of dydrogesterone ‘modified release’ 10 mg versus dydrogesterone ‘immediate release’ 10 mg tablets in the management of endometriosis-associated chronic pelvic pain.
The secondary objective is to assess the quality of life in subjects with endometriosis treated with dydrogesterone ‘modified’ versus ‘immediate release’ apart from the additional objective of assessing the reduction in the size of endometriosis with both medicines.
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