Cocaine abuse remains a serious problem worldwide. The United Nations Office on Drugs and Crime estimates that cocaine, which is a purified extract from the leaves of coca plant, is used by as many as 21 million people worldwide, with about 1 per cent of these individuals becoming addicted.
Cocaine's a hell of a drug, said the late R&B singer Rick James. What more apt catchphrase could there be to describe the harmful effects of this powerful stimulant.
Currently, there is no FDA-approved medication for the treatment of cocaine dependence. Developing a drug for treating cocaine addiction is Catalyst Pharmaceutical Partners Inc. (CPRX: Quote), a development-stage specialty pharmaceutical company.
For readers who are new to Catalyst Pharma, here's a brief overview of its pipeline and the upcoming events to watch out for...
The Coral Gables, Florida-based Catalyst Pharma is focused on developing prescription drugs to fight addictions, manage pain and treat diseases of the central nervous system such as epilepsy.
The company has two products under clinical development namely,
* CPP-109 for the treatment of addiction to cocaine, methamphetamine and other addictive substances. CPP-109 is Catalyst Pharma's version of Vigabatrin, an antiepilepsy drug approved in the United Kingdom in 1989. CPP-109 works by increasing the levels of the chemical GABA in the brain, which then lowers the level of dopamine, thereby producing a calming effect, increasing relaxation and reducing stress and anxiety.
* CPP-115 to combat drug addiction, including opiate addiction in managing pain and to treat epilepsy (initially infantile spasms), cocaine addiction and other select central nervous system indications. CPP-115 is more potent than CPP-109.
Both CPP-109 and CPP-115 have been granted "Fast Track" status by the FDA for the treatment of cocaine addiction.
CPP-109 is currently under phase II(b) testing. The phase II(b) trial is a 24-week placebo-controlled trial with 207 cocaine dependent subjects, designed to demonstrate that the rate of cocaine dependent subjects treated with CPP-109, who abstain from cocaine use in the last two weeks of the trial's treatment phase (weeks 8 and 9), will be higher than patients treated with placebo.
The company expects to report top-line results from its CPP-109 phase II(b) trial around the end of September 2012, about four months earlier than previously expected.
In May of this year, Catalyst Pharma reported positive results from a phase I(a) study of CPP-115, with the compound proving to be safe and well tolerated across all dose levels. A Multiple Ascending Dose study with CPP-115 is planned for the first quarter of 2013.
A quick look at Catalyst Pharma's balance sheet...
Since inception in 2002, the company has incurred significant operating losses, and at March 31, 2012, had an accumulated deficit of $39 million. In the first quarter of 2012, the company's loss narrowed to $1.09 million or $0.04 per share from $1.52 million or $0.08 per share in the year-ago quarter. Being a development stage company, Catalyst Pharma has had no revenues from product sales to date.
Catalyst Pharma, which was notified by the NASDAQ of not being in compliance with the minimum bid price requirement on June 21, 2012, regained compliance with the $1.00 minimum bid price rule on August 3.
The company went public in November 2006, pricing its IPO at $6 per share. The shares have thus far hit a 52-week low of $0.50 and a 52-week high of $1.90. CPRX is currently up 0.14% trading at $1.40.
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by RTT Staff Writer
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