(PRWEB) June 9, 2002
TORONTO, Ontario, June 7 - Following the decision of the United States Food and Drug Administration (FDA) to approve GlaxoSmithKline's supplemental New Drug Application (sNDA) that permits marketing of Lotronex (alosetron hydrochloride) with restrictions for women with diarrhea-predominant irritable bowel syndrome, Corey Miller, coordinator of the Lotronex Action Group (LAG), and Jeffrey Roberts, President and Founder of the Irritable Bowel Syndrome Self Help Group and coordinator of the Lotronex Action Group, jointly commented:
"We applaud both GSK and the FDA for resolving many of the issues surrounding access to this drug.
We are pleased with the initial method for access, however we hope that this onerous method of access will be loosened overtime for patients continuing to show positive results from the use of the medication.
A catastrophic mistake was averted and individuals can now breath a sigh of relief in terms of access, albeit, restricted, to a medicine that gave many back their day-to-day lives."
Background on Lotronex
Lotronex received FDA approval for marketing in the U.S. on February 9, 2000. On November 28, 2000, after extensive discussion with the FDA, GlaxoSmithKline voluntarily withdrew Lotronex from the U.S. market.
In December 2001, GSK filed a supplemental application seeking FDA approval to allow the reintroduction of Lotronex tablets, under modified conditions of use and with restrictions imposed by a risk management plan, for women with diarrhea-predominant IBS who have failed with other therapy.
About the Lotronex Action Group:
The Lotronex Action Group was organized by members of the IBS Self Help Group (http://www.ibsgroup.org) and former Lotronex users.
The Lotronex Action Group (LAG) was seeking access to the medicine Lotronex (alosetron hydrochloride). LAG ultimately seeks permanent access and safe distribution of the medicine to those diagnosed with IBS-Diarrhea.
The Lotronex Action Group believes the medicine to be safe, if dispensed properly, and that the benefits of Lotronex far outweigh the potential risk for adverse side affects.
About the Irritable Bowel Syndrome (IBS) Self Help Group:
The IBS Self Help Group is the premier internet self help health site about Irritable Bowel Syndrome, with more than 12,000 members.
The IBS Self Help Group (ibsgroup.org), formed in 1987, is in support of those who suffer from IBS, those who are looking for support for someone who has IBS, and medical professionals who want to learn more about IBS. The IBS website was launched in May 1995. The IBS Self Help Group website provides access to bulletin and chat boards, book list and store, medication listings, diagnosis and treatment, clinical study listings and support groups.
Irritable Bowel Syndrome (IBS) Self Help and Support Group
Jeffrey Roberts, President and Founder
Lotronex Action Group