Nelson Vergel
Founder, ExcelMale.com
Repros Therapeutics Receives Complete Response Letter From FDA for Enclomiphene
THE WOODLANDS, Texas, Dec. 1, 2015 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application for enclomiphene for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. A Complete Response Letter is a communication from theFDA that informs companies that an application cannot be approved in its present form.
In the letter, the FDA stated that, based on recent scientific developments, the design of enclomiphene Phase 3 studies is no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an additional Phase 3 study or studies to support approval in the target population. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase 3 program.
Repros plans to work with the FDA to determine an appropriate path forward to address these comments. "We are disappointed that the FDA has taken this position without the benefit of an advisory committee recommendation," said
Joseph Podolski, President and CEO of Repros. "We plan to work closely with the Agency to gain more information to determine the appropriate next steps regarding the enclomiphene application."
THE WOODLANDS, Texas, Dec. 1, 2015 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application for enclomiphene for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function. A Complete Response Letter is a communication from theFDA that informs companies that an application cannot be approved in its present form.
In the letter, the FDA stated that, based on recent scientific developments, the design of enclomiphene Phase 3 studies is no longer adequate to demonstrate clinical benefit and recommended that Repros conduct an additional Phase 3 study or studies to support approval in the target population. The FDA also noted concerns regarding study entry criteria, titration and bioanalytical method validation in the Phase 3 program.
Repros plans to work with the FDA to determine an appropriate path forward to address these comments. "We are disappointed that the FDA has taken this position without the benefit of an advisory committee recommendation," said
Joseph Podolski, President and CEO of Repros. "We plan to work closely with the Agency to gain more information to determine the appropriate next steps regarding the enclomiphene application."
