Repros Therapeutics (NASDAQ: RPRX) said today that following a teleconference with the FDA, the agency may be willing to lift the clinical hold status of Proellex if Repros can modify the study design. Clinical studies of the drug, which is under investigation for the treatment for uterine fibroids and endometriosis, were halted last year due liver enzymes changes at higher doses. Those changes were linked to serious adverse events.
In early April Repros asked the FDA lift the clinical hold to allow the company to test Proellex at a lower dose. At that time Repros said it attempted to respond to all of the FDA's concerns about the drug safety. While the FDA said that not all of their concerns were answered, it added that if Repros can modify the trial from a parallel design to an escalating dose design, it would allow the clinical hold to be lifted. Repros said it will submit a protocol as soon as possible, though the company warned that there's no guarantee the FDA will remove the hold.
- here's Repros' release