No safety data available, Conduct Phase-III CT: CDSCO Panel Tells Akums on Norethindrone, Estradiol, Relugolix film-coated tablet

This came after Akum Drugs and Pharmaceuticals presented their proposal for the FDC Norethindrone Acetate USP 0.5mg plus Estradiol (as Hemihydrate) USP eq. to Anhydrous Estradiol 1mg plus Relugolix 40mg film-coated tablet along with justification for the clinical trial waiver before the committee.

An oral fixed-dose combination of relugolix/estradiol/norethisterone (also known as norethindrone) acetate is approved for the management of heavy menstrual bleeding associated with uterine fibroids in the USA and management of moderate to severe symptoms of uterine fibroids in the EU.

Relugolix is used in men to treat advanced prostate cancer. Relugolix is a type of medicine called a gonadotropin-releasing hormone (GnRH) antagonist. It helps treat prostate cancer by lowering the amount of testosterone hormone in the blood. In some patients, testosterone will cause prostate cancer to grow larger.

Estradiol is a medication used to manage and treat postmenopausal symptoms and for women who have had hysterectomies. Estradiol is the most potent estrogen (E2) in the human body. Postmenopausal symptoms include but are not limited to vaginal dryness, itchiness, dysuria, and many more.

Norethindrone acetate is a synthetic form of the hormone progesterone. This medication is a hormone replacement to balance progesterone in your body. Norethindrone acetate treats endometriosis, uterine bleeding caused by abnormal hormone levels, and secondary amenorrhea.

At the recent SEC meeting for Reproduction and Urology held on 19th December 2023, the expert panel reviewed the proposal also with the justification for CT waiver for the FDC Norethindrone Acetate plus Estradiol plus Relugolix coated tablet presented by the drug major Akum Drugs and Pharmaceutical.

After detailed deliberation, the committee noted that there is no safety and efficacy data available on the proposed FDC in the Indian population.

Hence, the committee recommended that the firm should conduct a Phase-III clinical trial for the proposal indication.

Accordingly, the expert panel suggested that the firm should submit the clinical trial protocol to CDSCO for review by the committee.

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