MSN Lab gets CDSCO Panel nod for phase III CT of Elagolix Tablets
New Delhi: The drug major MSN Laboratories has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the proposed Phase III clinical trial of the Elagolix Tablets 150mg & 200mg as per the protocol.
This came in line with the proposal presented by the drug maker MSN Laboratories for grant of permission for manufacturing and marketing of the drug Elagolix Tablets 150mg & 200mg.
In addition, the drug maker MSN Laboratories has submitted the result of bioequivalence (BE) Study and Phase III clinical trial protocol before the committee.
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.
Elagolix is an orally-administered, nonpeptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signaling 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 progesterone.
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