Reuters logo
UPDATE 1-Repros receives FDA advice on drug's trial design
April 30, 2010 / 11:19 AM / 8 years ago

UPDATE 1-Repros receives FDA advice on drug's trial design

* Receives FDA guidance on clinical hold status of Proellex

* To modify protocol and submit new design to the FDA

* Shares up about 13 pct pre-market

April 30 (Reuters) - Repros Therapeutics Inc (RPRX.O) said the U.S. health regulator would consider lifting the clinical hold on the company’s lead drug to treat uterine fibroids if it agrees to modify its trial design.

The company said the U.S. Food and Drug Administration (FDA) would consider placing the experimental drug Proellex on partial clinical hold to allow low-dose trial to be conducted.

Repros said it has agreed to modify the protocol and submit the new design to the regulator as soon as possible.

Earlier in the month, the company had requested the FDA to lift the clinical hold saying a safe oral dose can be developed based on data from completed studies. [ID:nSGE63S0EE]

Development of Proellex was put on hold by the FDA in 2009, after patients receiving higher doses of the drug showed signs of liver toxicity.

Shares of the company were up about 13 percent at 98 cents in pre-market trade. They closed at 87 cents Thursday on Nasdaq. (Reporting by Krishnakali Sengupta in Bangalore; Editing by Roshni Menon)

Our Standards:The Thomson Reuters Trust Principles.
0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below