Plan to Apply for MFDS Product Approval Within the Year
[Asia Economy Reporter Lee Gwan-joo] CTCC Bio announced on the 24th that it has received the domestic Phase 3 clinical trial report for the premature ejaculation and erectile dysfunction combination drug 'CDFR0812-15' (50 mg) and confirmed its efficacy and safety.
CTCC Bio's combination drug for premature ejaculation and erectile dysfunction is a compound of Clomipramine HCL (Condensia tablet), used for treating premature ejaculation, and Sildenafil citrate (Viagra tablet), an erectile dysfunction treatment.
Since 2019, CTCC Bio has conducted clinical trials at 22 hospitals involving 792 male patients aged 19 and older with premature ejaculation to compare efficacy and safety. The clinical trial was prospective, randomized, double-blind, placebo-controlled, with three dosage groups, parallel, and multicenter, with administration and observation periods exceeding 20 weeks.
According to the clinical results, compared to the monotherapy of each control group (Condensia tablet, Viagra tablet), the time to ejaculation after vaginal insertion (IELT) was significantly increased, and safety was reported to be comparable to the control groups, the company explained.
The company plans to apply for product approval from the Ministry of Food and Drug Safety within the year. Lee Min-gu, CEO of CTCC Bio, stated, "After launching the combination drug, we plan to leverage PMS (post-marketing surveillance) to gain market dominance and proceed with approvals in regions recognizing domestic clinical data," adding, "Europe and the United States will undergo additional inter-ethnic variability studies for future approvals."
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