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  • No safety data...

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

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-01-12T18:00:03+05:30  |  Updated On 22 March 2024 10:24 PM IST
Akums Drugs, Tamil Nadu Agricultural University collaborate for pharmaceutical innovation
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New Delhi: Citing that there is no safety and efficacy data, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Akum Drugs and Pharmaceuticals to conduct the phase III clinical trial of the fixed-dose combination drug (FDC) Norethindrone Acetate plus Estradiol plus Relugolix 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.

Also Read: Submit PK-PD data of 3 cohorts for 7 days: CDSCO Panel Tells Shilpa Medicare on Ondansetron ER Inj Suspension IM study

akums drugcdsconorethindrone acetateestradiolrelugolixakums drugs and pharma
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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