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  • Conduct Phase III CT...

Conduct Phase III CT of Triptorelin to treat chronic pain linked to endometriosis: CDSCO Panel Tells Dr Reddy's Lab

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-01-11T18:00:37+05:30  |  Updated On 22 March 2024 10:25 PM IST
Dr Reddys Labs inks pact with Henlius for commercialization of multiple myeloma injection HLX15 in US, Europe
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New Delhi: Citing that the pharmaceutical giant Dr. Reddy's Laboratories has not supplied data on the Indian population for the management and relief of chronic pain associated with endometriosis for the drug Triptorelin powder for injection 3.75mg, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the firm to conduct the Phase III clinical trial of the Triptorelin powder for injection 3.75mg for the management and relief of chronic pain associated with endometriosis.

This came after the drug major Dr. Reddy's Laboratories presented its proposal for a grant of permission (additional Indication) for the management and relief of chronic pain associated with endometriosis for the drug Triptorelin powder for injection 3.75mg along with justification for Bio and clinical trial (CT) waiver before the Committee.

The Committee noted that the firm has not provided Indian population data for a proposed additional indication.

Triptorelin is a gonadotropin-releasing hormone (GnRH) agonist that is a potent inhibitor of the synthesis of testosterone (in men) and estrogen (in women) and is used to treat advanced prostate cancer.

Triptorelin reduces the amount of sex hormones (testosterone in men and estrogen in women). It works by decreasing the blood levels of testosterone in males. Triptorelin also acts by shutting off hormones made by the ovaries (female reproductive organs), so the estrogen (one of the hormones that causes females to have periods) level is lowered.

Triptorelin is a synthetic agonist analog of gonadotropin-releasing hormone (GnRH). Animal studies comparing triptorelin to native GnRH found that triptorelin had 13-fold higher releasing activity for luteinizing hormone, and 21-fold higher releasing activity for follicle-stimulating hormone

At the recent SEC meeting for reproduction and urology held on 19th December 2023, the expert panel reviewed the proposal presented by the drug major Dr Reddy Laboratories for the grant of additional Indication for the management and relief of chronic pain associated with endometriosis for the drug Triptorelin powder for injection 3.75mg along with justification for Bio and CT waiver.

The Committee observed that for a proposed additional indication, the firm has not supplied data on the population of Indians.

After detailed deliberation, the committee recommended that the firm should conduct a Phase-III clinical trial for a proposed additional indication for which the firm should submit Phase-III clinical trial protocol to CDSCO for further review by the Committee.

Also Read: AstraZeneca Gets CDSCO Panel Nod to Study anti-cancer drug Dato-DXd and Durvalumab

dr reddys labscdscoTriptorelinendometriosisDr Reddy’s
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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