Synokem gets CDSCO panel nod to study Dyhydogestrone as part of Assisted Reproductive Technology

Furthermore, in connection with the bioequivalence study, the firm state, "An open-label, randomized, balanced, two-treatment, two sequences, two-period, cross-over, single dose, oral bioequivalence study of Dydrogesterone film coated sustained release 30mg tablets (T) manufactured by Synokem Pharmaceuticals Ltd., India with Duphaston (Dydrogesterone tablets IP 10mg (Dose: 3x10mg) (R) manufactured by Abbott India Limited in normal healthy, adult female subjects under fasting condition."

Duphaston 10mg Tablet manufactured by Abbott India treats female infertility, relieves various menstrual problems like heavy unusual menstrual bleeding or pain as well as irregular periods, Premenstrual syndrome (PMS) and endometriosis. It also restores normal menstrual cycles in case periods have stopped before reaching menopause.

Dydrogesterone is a synthetic progesterone for menstrual cycle regulation, infertility treatment, prevention of miscarriage, and other conditions. Dydrogesterone helps to regulate the healthy growth and normal shedding of the uterus lining. Therefore, it may be useful in the treatment of menstrual disorders such as absent, irregular or painful menstrual periods, infertility, premenstrual syndrome and endometriosis.

Dydrogesterone is an orally active progestogen which acts directly on the uterus, producing a complete secretory endometrium in an estrogen-primed uterus. At therapeutic levels, dydrogesterone has no contraceptive effect as it does not inhibit or interfere with ovulation or the corpus luteum.

At the recent SEC meeting for Reproductive & Urology held on the 28th of February, the expert panel reviewed the proposal presented by the drug major Synokem Pharmaceuticals for the manufacturing and marketing of the drug Dyhydogestrone film coated sustained release Tablets 20/30mg for Luteal support as part of an Assisted Reproductive Technology (ART) treatment along with Phase III clinical trial protocol and BE protocol.

After detailed deliberation, the committee recommended for grant of permission to conduct the BE study and Phase III clinical trial as per the protocols presented by the firm subject to the condition that the age group of the study population in Phase III clinical trial should be ≥ 21 and ≤ 42 years of age and are planning to undergo ART.