By: Tomas Ronolski - AllPennyStocks.com News

Wednesday, December 4, 2013

The Centers for Disease Control and Prevention has determined that prescription drug abuse in the U.S. has reached epidemic proportion, citing an increase in opioid analgesic sales as a contributing factor. In 2010, drug poisoning, mostly in the form of overdoses, was attributed to more deaths than motor vehicle accidents in 31 states, according to CDC data. Deaths from prescribed opioid analgesics for the country totaled an amazing 16,651 in 2010, and that’s just specified deaths. It’s presumable that the drugs played a role in the 25-percent of drug-related deaths where an exact cause wasn’t provided. For comparison, in 1999, there were only 4,030 deaths from prescription opioid overdose. The CDC and Drug Enforcement Agency are working together to combat the growing rate of opioid abuse that is rising in tandem with overdose deaths. Tackling increasing overdose rates from a different angle, drug developers, such as Lightlake Therapeutics Inc. (OTCBB:LLTP), are working on innovative ways to rapidly reverse the overdose of prescription and illicit opioids.

London-based Lightlake is working on treatments for a variety of addictions and disorders, such as Binge Eating Disorder, or “BED,” and addictions to drugs including, cocaine, amphetamines and MDMA (the chemical used in ecstasy, but also abused in other forms). The company has successfully completed a Phase II clinical trial for BED and is planning a Phase II trial for Bulimia Nervosa. This clinical work is built upon Lightlake’s patents covering intranasal naloxone, which is also being used for its opioid clinical research.

Developed 50 years ago, naloxone is an opioid antagonist that, amongst other indications, is approved in injectable form to counteract life-threatening conditions of the central nervous and respiratory systems caused by opiate overdose.

In August, Lightlake partnered with the National Institute of Drug Abuse (NIDA), with the NIDA committing to sponsor a two-week clinical trial evaluating Lightlake’s new intranasal form of naloxone as a potential new therapy for opioid overdose. Moving quickly, the trial commenced on September 24. After Tuesday’s closing bell, Lightlake reported that the initial findings from the trial supports further clinical evaluation of the new delivery system. The data showed that the nasal spray could potentially deliver naloxone to the circulatory system at least as fast as the injectable form.

Lightlake intends to file an Investigation New Drug application with the Food and Drug Administration to initiate a larger-scale trial. The company believes that it could have new nasal application being brought to market in the next 12 to 18 months, assuming that everything goes well with the clinical research.

"Given our collaboration with NIDA and current understanding of the regulatory pathway with respect to our prospective opioid overdose reversal product, we anticipate incurring relatively low costs to reach an NDA submission with the FDA," said Kevin Pollack, CFO of Lightlake, in a statement.

"Upon the prospective approval and launch of our product, we expect significant market demand given the growing opioid addiction epidemic and the multiple substantial advantages of our intranasal delivery of naloxone over the current injectable delivery of naloxone," he added.

Lightlake is an interesting proposition as it meets milestones and maneuvers through clinical trials. Much like other biotechs, especially developmental firms, it’s going to need to raise some capital to fund upcoming trials and general operations, but some partnerships may help moderate some of those expenses. The company had a cash position of about $600,000 at the end of July, according to its 10-K filed with the SEC. Lightlake has collaboration agreements in place with Lloyds Pharmacy and Celesio AG to pursue funding options and strategic relationships. Celesio announced on October 24 that it agreed to be acquired by McKesson Corp. (NYSE:MCK) in a deal valued at $8.3 billion, forging a world power in drug distribution.

Trading at only 6 cents a share and with a market capitalization of $10 million, the wide-angle view is appealing. As always, some additional due diligence on the mid-stage clinical trials, depth of the partnerships and driving forces is required.

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