DynaGen Inc. expects to announce positive results this morningfrom a completed Phase II clinical study of its NicErase non-nicotine smoking cessation product -- a potential rival of thesuccessful nicotine transdermal patches launched last year.
Based on the trial data, DynaGen of Cambridge, Mass., expectsto file with the FDA in early 1993 to start a Phase III trial ofthe injectable NicErase product, according to Indu Muni, thecompany's president and chief executive officer.
If NicErase is shown to be as effective as nicotine patches inhelping to break the smoking habit, Muni predicts that NicErasecould grab up to 20 percent of the transdermal patch marketwithin a year of its introduction. The nicotine transdermalpatch market has been forecasted to grow to $500 million bythe mid-1990s.
Though Dynagen is the sole developer of NicErase, "chances arewe won't do it alone," Muni said. He said NicErase would becompetitive with transdermal patches, at about $285 to $350for a six-week regimen, but no price has been set yet.
As an injectable, NicErase poses none of the compliance issuesthat have arisen with transdermal patches, which are appliedby participants, Muni said. NicErase has also shown no addedrisk to users who continue to smoke during treatment, he said.
NicErase, which consists of a synthetic compound contained inDynaGen's proprietary controlled-release formulation, showedno clinically significant adverse effects in the completedplacebo-controlled study involving 40 participants. The datashowed that NicErase had some effect in reducing tobaccointake and the anxiety and craving associated with smokingwithdrawal, but DynaGen would be looking for stronger data inPhase II trial, Muni said.
The Phase II data were limited because participants receivedonly one of the six weekly subcutaneous injections planned inthe NicErase program, Muni said. DynaGen's program isintended to be used by smokers who are both motivated toquit and enrolled in a behavioral counseling program, but theparticipants in the Phase II study were not, he said.
DynaGen declines to make a detailed description of thesynthetic compound in NicErase, but Muni said itspharmacological effects are similar to nicotine without theinteraction with brain cell receptors.
-- Ray Potter Senior Editor
(c) 1997 American Health Consultants. All rights reserved.