Endo says osteoarthritis pain candidate failed in late-stage study

Sep. 26, 2022 10:25 AM ETEndo International plc (ENDPQ)By: Dulan Lokuwithana, SA News Editor

Knee painful - skeleton x-ray.


  • Endo International plc (OTCPK:ENDPQ) announced Monday that an experimental pain therapy the generic drugmaker has partnered with Taiwan Liposome Company for knee osteoarthritis did not outperform the placebo in a Phase 3 study.
  • The treatment, TLC599, also known as dexamethasone sodium phosphate extended-release liposome injectable suspension, led to an improvement on the primary endpoint, defined as the 12-week change in a pain measure from the baseline.
  • However, citing topline data from the study, the company said the difference was not statistically significant compared to the placebo.
  • The outcome has prompted ENDPQ to evaluate its options for the candidate with TPL, which has already received $30M for the partnership.
  • The deal announced in June required ENDPQ to pay TPL $110M in milestone payments to TPL, including $20M linked to positive Phase 3 results, which is unlikely to be paid in 2022.

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