Komipharm Voluntarily Withdraws Application for Phase 2 Clinical Trial of Cancer Pain Treatment in South Korea
[Asia Economy Reporter Jang Hyowon] Comipharm announced on the 16th that it has voluntarily withdrawn its application for the MFDS (Ministry of Food and Drug Safety) Phase 2 clinical trial plan for PAX-1 (oral) administered orally to cancer patients taking opioid analgesics.
The company stated, "There was a difference of opinion with the review agency, the MFDS, regarding the efficacy evaluation (dosage groups) in the previously submitted clinical trial plan (protocol), leading to the decision to voluntarily withdraw."
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It added, "We plan to redesign the existing Phase 2 clinical trial plan (protocol) by reflecting the opinions of the MFDS and clinical trial institutions, and reapply as soon as possible."
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