CDSCO asks Akums Drugs to revise phase III CT protocol for abortion drug Mifepristone
New Delhi: Recommending to exclude patients using any contraceptive method other than conventional methods, barrier, male or female sterilization, the Subject Expert Committee (SEC) functional under Central Drug Standard Organization (CDSCO) has directed Akums Drugs and Pharmaceuticals to revise the phase III clinical trial protocol for abortion drug Mifepristone Tablets 10/25mg.
The drug Mifepristone falls under the National List of Essential Medicines. It is a steroidal anti-progestin drug that is used to induce abortion. It functions as a competitive progesterone receptor antagonist in the presence of progesterone. It causes the pregnancy to end by blocking the hormone progesterone, which is needed to keep the pregnancy going. Before taking these pills, it is recommended that one should consult a gynecologist.
Moving to the launch of the said drug the clinical trial and Bioequivalence Study waiver was presented by Akums Drugs and Pharmaceuticals for granting permission to manufacture Mifepristone Tablet 10mg & 25mg at the 50th Subject Expert Committee meeting held last year.
Responding to this committee recommended that the firm should conduct a clinical trial to assess the efficacy and long-term safety of the drug in the proposed indication. Committee also added that the firm should submit the clinical trial protocol for further review.
Now in the 58th SEC meeting held on 25.02.2021 firm presented Phase III Clinical Trial protocol for Mifepristone Tablets 10/25mg.
Committee reviewed the clinical trial protocol in its recent meeting and after detailed deliberation, the committee recommended the firm to revise the clinical trial protocol according to bellow conditions.
1. Patients with age group 18 to 40 years are to be included in the study.
2. Patients with any coagulation disorder are to be excluded.
3. Patients using any contraceptive method other than conventional methods, barrier, male or female sterilization, is to be excluded.
4. Justification for randomization of patients in treatment groups in 3:1:1 ratio.
5. Trans-abdominal ultrasound to be carried in addition to transvaginal ultrasound in screening and follow-up of the patients.
6. Biopsy test need not be carried out for patients not having any menstrual disorders. For the patients with menstrual disorder, the biopsy can be carried out during screening and at the end of the study.
7. Statistical justification for sample size.
The committee also added that the firm should submit the revised protocol before the committee for further consideration.