Sun Pharma Gets CDSCO Panel Nod To Study Elagolix tablet

However, this approval is subjected to a condition that the firm should include both a T-score and a Z-score for monitoring bone marrow density (BMD).

This came after the firm presented the revised Phase III clinical trial protocol of Elagolix (150 and 200 mg) before the committee, in light of an earlier SEC recommendation dated July 28, 2012.

Elagolix is a gonadotropin-releasing hormone receptor antagonist used to treat moderate to severe pain in endometriosis.

Endometriosis develops when tissue that is similar to the kind that is normally located in the uterus starts to grow outside of the uterus. Such growth leads to various symptoms like pain during periods, pelvic pain between periods, and pain during sexual intercourse. The growths themselves are referred to as lesions and frequently develop on the ovaries, fallopian tubes, and other areas around the uterus, including the bowels or bladder. The growth of these lesions is dependent on the estrogen hormone.

Elagolix is an orally administered nonpeptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signalling by binding competitively to GnRH receptors in the pituitary gland. Administration of elagolix results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesteron.

Earlier, the Medical Dialogues Team had reported that, in response to pharma major Sun Pharma's proposal to manufacture and market the drug Elagolix in 150 mg and 200 mg tablets by conducting a Phase-III clinical trial in the country, the Central Drug Standard Control Organization (CDSCO) panel had recommended to conduct a Phase III clinical trial of Elagolix 150 mg tablets for test arm 1 by monitoring bone marrow density for six months and with the follow-up of serum oestrogen levels of the subjects.

Furthermore, regarding the Phase III study of Elagolix 200mg Tablets with Test Arm 2, the committee raised safety concerns with subjects at higher doses and did not consider the request to conduct a Phase III study with Test Arm 2 (Elagolix 200mg Tablets).

In light of this, during the earlier SEC meeting for Reproductive and Urology, the committee recommended that the company submit the revised protocol for additional review.

Now, in continuation, at the recent SEC meeting for Reproductive and Urology held on September 28th, 2022, the expert panel extensively reviewed the revised Phase III clinical trial protocol of Elagolix Tablets 150 mg and 200 mg presented by drug major Sun Pharma.

After detailed deliberation, the committee recommended the grant of permission to conduct the study as per the presented protocol, subject to the condition that the firm should include both T-score and Z-score for monitoring of bone marrow density (BMD).