US FDA reaffirms hold on oral Proellex trials prompting Repros rethink

By Gareth Macdonald

- Last updated on GMT

iStock/jarun011
iStock/jarun011

Related tags Food and drug administration

The US FDA has told Repros Therapeutics Inc. a new trial is needed to prove oral Proellex is safe, prompting the firm to consider refocusing on a vaginally-delivered formulation of the endometriosis candidate.

The Texan firm mooted the change of development strategy in a financial filing this week, explaining it “is assessing increasing its focus on its uterine fibroid and endometriosis development program utilizing a vaginal drug delivery program for telapristone acetate [Proellex]​.”

CEO Larry Dillaha said: “Our discussions with the FDA, and their guidance that a large safety data base will be required to continue the development of Proellex, indicate that a much larger clinical trial, with associated time and cost requirements, would be necessary​."

Liver concerns

The US Food and Drug Administration (FDA) ordered Repros to halt clinical trials of oral Proellex in 2009 after a number of patients demonstrated increased liver enzyme activity, which can be an indication of toxicity.

The agency later downgraded the clinical hold to a partial clinical hold, allowing Repros to trial a low dose oral version of the drug.

However, Repros subsequent efforts to have the partial hold lifted have not been succesful.

Delivery tech

According to Repros the vaginally-delivered formulation of Proellex has shown promise.

Dillaha explained that: “Clinical work done to date suggests that vaginal delivery of telapristone acetate has the potential to yield good efficacy with significantly lower systemic blood levels​.“

He added: “We intend to leverage drug delivery technology that could offer dosing less frequently than once per day​."

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