SAN DIEGO, July 26 -. Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced that oral nalmefene hydrochloride, an opiate antagonist under development by the company, demonstrated positive results in a pilot Phase 2 clinical trial for smoking cessation. In a single center, randomized, placebo-controlled study in which 76 smokers were enrolled, patients in the nalmefene 40mg group demonstrated numerically higher abstinence rates at all timepoints relative to placebo. Patients in the nalmefene 80mg group did not consistently achieve abstinence rates that were numerically superior to placebo. The study was not powered to demonstrate statistical significance.
Nalmefene was generally well tolerated, with an adverse event profile similar to that observed in studies previously conducted with nalmefene. The most commonly reported adverse events were insomnia and nausea. The adverse events tended to be transient in nature and largely resolved after the first week on study drug. Elevation in liver enzymes was observed with a similar frequency in all groups.
Somaxon's Chief Medical Officer Phil Jochelson, MD commented, "We are encouraged by the results of our first smoking cessation clinical study which was designed to be exploratory in nature. We are intrigued with the observation that the nalmefene 40 mg treated patients maintained higher abstinence rates relative to placebo."
Ken Cohen, Somaxon's President and Chief Executive Officer commented, "Nalmefene is a promising compound. We are currently studying this product in a large clinical trial for the treatment of pathological gambling. We intend to await the results of that trial, which we expect early next year, before we determine our further clinical development plans. The results of this pilot smoking cessation trial give us the opportunity to potentially develop nalmefene for multiple indications in large markets with unmet medical needs."
About Smoking
Cigarette smoking remains the leading preventable cause of illness and premature death in the United States. In 2005, the U.S. Centers for Disease Control and Prevention estimated that approximately 45 million, or 22%, of adults in the United States are smokers. The impact of nicotine dependence in terms of morbidity, mortality and economic costs to society is enormous. According to the Surgeon General, tobacco usage kills more than 440,000 people in the United States annually. Smoking is linked to an estimated $75 billion in medical expenditures in the United States per year. When indirect costs such as lost productivity due to smoking are considered, the costs increase significantly to approximately $158 billion. Nearly 41% of smokers attempt to quit smoking each year but only about 10% achieve and maintain abstinence.
About Nalmefene
Nalmefene, an opioid antagonist, is approved and has been used for over 10 years in the United States in an intravenous form for the reversal of opioid drug effects. Somaxon in-licensed the North American development and commercial rights to an oral form of nalmefene and patents for its use in the treatment of impulse control disorders, nicotine dependence and other conditions. The impulse control disorder category includes a number of serious conditions, including pathological gambling, kleptomania, pyromania, intermittent explosive disorder and compulsive buying. There are no FDA approved therapies for any of these disorders. The University of Chicago's 1999 Gambling Impact and Behavior Study estimates that in the United States alone, there are approximately 2.5 million pathological gamblers, 3 million problem gamblers and an additional 15 million people who are at-risk gamblers. In a multi-center Phase 2 clinical trial conducted by Somaxon's licensor, nalmefene was shown to be statistically superior to placebo in limiting gambling behavior and reducing the frequency and intensity of gambling thoughts/urges. Based on these results, Somaxon has initiated a confirmatory Phase 2/3 clinical trial for pathological gambling. The company expects results from the pathological gambling trial to be available in early 2007.
About Somaxon Pharmaceuticals, Inc.
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology. Somaxon's lead product candidate, SILENOR(TM) (doxepin HCl), is in Phase 3 clinical trials for the treatment of insomnia. Nalmefene HCl is in a Phase 2/3 clinical trial for pathological gambling and has completed a pilot Phase 2 trial for smoking cessation. Acamprosate Ca, a potential treatment for movement disorders, is currently in formulation development.
For more information, please visit the company's web site at http://www.somaxon.com.
Somaxon cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Somaxon that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Somaxon's business, including, without limitation: the potential for nalmefene to receive regulatory approval for one or more indications on a timely basis or at all; the progress and timing of Somaxon's clinical trials, including the potential to replicate in future trials the results observed in the pilot smoking cessation trial for nalmefene and the ability to demonstrate sufficient therapeutic efficacy and safety for SILENOR(TM) and nalmefene in Somaxon's other pending trials; the market potential for smoking cessation, compulsive gambling, insomnia and other target markets, and Somaxon's ability to compete in those markets; the scope and validity of patent protection for Somaxon's product candidates; Somaxon's ability to attract and retain key personnel; and other risks detailed in Somaxon's prior press releases as well as in periodic filings with the Securities and Exchange Commission.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Somaxon undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof.
This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Contacts: Jeff Raser
SVP, Sales and Marketing
(858) 480-0404
Rob Whetstone
PondelWilkinson, Inc.
(310) 279-5963
In addition to online casino news hot off the presses, OCN shows you the best first deposit bonuses at the best online casinos on the web. We've spared you the search by putting together a list of the latest and greatest first deposit bonuses around. So, all you have to do is click and enjoy!
| Name | First Deposit |
|---|
| 100% up to 200$ |
| 100% up to 400$ |
| 500$ |
| up to 350$ |
| 300% uo to 300€ |
| 100% match upto $200 |
| 1000% |
Club Vegas USA is latest online casino Powered by Rival to be released. Rival is one of the up and c...
Reuters reported recently that the United States is not worried about having to pay $100 billion in ...
The release of a new game is always a special event in the gambling industry, but when Microgaming, ...
The sixth annual European i-Gaming Congress and Expo got underway at the spacious Barcelona Diagonal...
The United States government released proposed guidelines for the Unlawful Internet Gambling Enforce...
On October 1, 2007 the Federal Reserve and the Department of the Treasury released their joint repor...
Although the passage of the UIGEA last year made it difficult for American players to gamble online,...
Are the new lax gambling laws causing more and more Britons to be under the sway of compulsive gambl...
You may have a surprise in your Full Tilt Poker Account today! After recent allegations that bots we...
Coming off a 26th-place finish at the World Series of Poker, Rancho Mirage's Roy Winston won the Bor...
But the Gloucester Township homemaker never expected another fight -- this time with bureaucrats -- ...
It should come as a surprise to no one that charity-poker games have emerged in recent years as an i...
Spurred by the three-month success of high stakes poker, the Naples-Fort Myers Greyhound Track’s pok...
Online Casino Group Betfair has announced that it has boosted its IT energy efficiency to support it...
Rumors have been circulating for a while now about the future of 32Red.com and its Gibraltar-based B...
CryptoLogic has announced that they have received exclusive rights to make slots and other casino ga...
Since the beginning of the U.S. Presidents first term, the Bush administration has been trying to ke...
The coastal casino in the State of Mississippi have had a diffilcutl few years, yet it seems that th...
Her Majesty Queen Elizabeth II recently found that not only was she one of the most richest women in...
It seems that there is no limit to how low some online casinos can go in order to secure a profit. V...
After a 10-month investigation into the slimy world of Internet "casinos or sports books", Americas ...
It looks like the team behind Online-Casinos.com want to make their online casino portal a fun place...
Positive Experience Begins Even Before Guests Step Out of Their Cars at Harrah's, St. Louis Casino &...
Penghu, a set of islets off Taiwan, is trying to be the next Macao by building a casino town to lure...
The battles against the draconian UIGEA seems to be gaining momentum in the world courts. Here are t...
The Online Casino industry has experienced the worst setback that it ever has since UIGEA. However, ...
The recent British Online Gambling Act has sent the online casino industry into a flurry of exciteme...
As agreed by all interested parties, the hearing that was to take place on the issue of repealing th...
eCOGRA, the world's Internet Pilce Officer, has announced that it approves of the measures taken in ...
Playtech has announced that its Cheif Financial Officer, Shuki Barak, is leaving the group. ...
The Gambling Act is the first peice of legislation that has been passed in the UK about gambling. Wh...
Have you committed a crime in order to pay gambling debts? When you gamble, do you go back another d...
America’s Attorney General Alberto Gonzales has at long last bowed to pressure and has resigned from...
As of today, online gambling in the United Kingdom, as well as advertising from online casino operat...
PartyGaming PartyGaming published their first-half interim results this week, reporting an expected ...
In papers filed today, the US District Court of New Jersey, Trenton Division, has granted a motion o...
Malta is the next online casino superpower, it seems. Here is the storty how a little country draws ...
For some addicts, a casino can be the root of all evils. For others, a fix can come from visiting th...
The new piece of legislation banning advertisements in the UK has caused some stir in the online gam...
| Name | Payout | |
|---|---|---|
| Club Vegas USA | 99% |
|
| Sun Palace Casino | 98.2% |
|
| Club USA Casino | 97.5% |
|
| Cool Cat Casino | 98% |
|
| LuckyAce Poker | 99.4% |
|
| Rushmore Casino | 97.2% |
|
| LuckyAce Casino | 98.3% |
|
Online Casino News - news
from the world of
online casinos RSS Feed.
The OCN directory is currently in development and will be available soon. If you are interested in adding a link, just click on the “Add Link” button. Thanks for your patience.
You do not need prior permission to link to any of the pages on this site. Limited copyright is granted for you to use and/or republish any of the articles on this site for any legitimate media purpose as long as you reference OCN as the source, and include a link referring the reader to the OCN site.