Abbott Gets CDSCO Panel Nod to Study Dydrogesterone Modified Release Tablets
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has given its nod to drug major Abbott for conducting the Phase III clinical trial of Dydrogesterone Modified Release Tablets 30mg (Additional Strength).
In addition to the above, the committee recommended that the additional objective should be included as a secondary objective stating that " In women diagnosed to be having endometrioma on sonography at the time of recruitment, any change in the size of endometrioma will be noted at the end of the study"
This came after the firm presented a Phase III clinical trial protocol before the committee.
Dydrogesterone is a synthetic progesterone for menstrual cycle regulation, infertility treatment, prevention of miscarriage, and other conditions.
Dydrogesterone is a progestogen (a synthetic form of progesterone hormone), used to treat progesterone deficiency (irregular periods, etc.) and other symptoms due to increased activity of estrogen. It belongs to the 'hormonal replacement therapy' group of medicines.
Dydrogesterone is an orally active progestogen that acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum.
At the recent SEC meeting for reproduction and urology held on 20 September 2023, the expert panel reviewed the Phase III clinical trial protocol of the Synthetic Progesterone Dydrogesterone modified release tablets 30mg (additional strength) presented by the drug major Abbott.
The committee noted that the firm is already holding a bioequivalence (BE) No Objection Certificate (NOC).
After detailed deliberation, the committee recommended that an additional objective should be included as a secondary objective stating that " In women diagnosed to be having endometrioma on sonography at the time of recruitment, any change in the size of endometrioma will be noted at the end of the study".
In continuation, the expert panel recommended the grant of permission to conduct the Phase III clinical trial subject to the above condition.
Furthermore, the committee stated that the firm should submit a bioequivalence report and get evaluated by the SEC committee before initiating the Phase III clinical trial.
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