CORAL GABLES, Fla. – July 10, 2007 – Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a company specializing in the development of prescription drugs for addiction treatments, has announced the initiation of a pivotal Phase II clinical trial in the United States. This trial will assess the safety and efficacy of CPP-109, a novel pharmaceutical compound, for the treatment of cocaine dependence. CPP-109 utilizes vigabatrin, an existing epilepsy medication, and is being investigated for its potential to address cocaine addiction.
This groundbreaking clinical trial follows extensive preclinical research led by Stephen Dewey at Brookhaven National Laboratory of the U.S. Department of Energy, and Dr. Jonathan Brodie, a psychiatrist at New York University School of Medicine. Their studies have indicated that vigabatrin holds significant promise in treating addiction to various substances, including cocaine. Catalyst Pharmaceutical Partners has secured exclusive rights from Brookhaven National Laboratory to develop and commercialize vigabatrin for the treatment of a wide range of substance addictions.
Patrick J. McEnany, Chief Executive Officer of Catalyst Pharmaceutical Partners, expressed enthusiasm about this significant step: “The commencement of this large-scale U.S. Phase II study of CPP-109 marks a crucial milestone in our efforts to develop an effective treatment for cocaine addiction. We are optimistic that CPP-109 can offer a much-needed, safe, and effective therapeutic option for patients struggling with cocaine dependence, as well as for the healthcare professionals who are dedicated to their care.”
The Phase II trial is meticulously designed as a randomized, double-blind, placebo-controlled, multicenter study. It aims to rigorously evaluate the potential of CPP-109 in treating cocaine addiction across a cohort of 180 patients diagnosed with cocaine dependence. These participants will be recruited from 10 leading addiction treatment centers throughout the United States. The treatment period will span 12 weeks, followed by an additional 12 weeks of observation to monitor long-term outcomes. The primary goal of this study is to determine if a significantly higher percentage of patients treated with CPP-109 achieve cocaine abstinence during the final two weeks of treatment (Weeks 11 and 12) compared to those receiving a placebo. Furthermore, the trial will assess several secondary endpoints focused on measuring reductions in cocaine use among participants.
Douglas Winship, Vice President of Regulatory Operations for Catalyst Pharmaceutical Partners, highlighted the significance of this trial in the context of existing treatment options: “Previous pilot studies conducted in Mexico have demonstrated vigabatrin’s potential as a non-addictive treatment for both cocaine and methamphetamine addiction. We are now eager to further explore the therapeutic benefits of CPP-109 in a larger, well-controlled, placebo-based clinical trial under our sponsorship. Currently, there are no approved pharmacological treatments specifically for cocaine addiction. Effective drug therapies are urgently needed to augment the outcomes of behavioral therapies administered by addiction specialists and to decrease the rates of relapse.”
Catalyst Pharmaceutical Partners anticipates commencing patient enrollment in the Phase II clinical trial pending Institutional Review Board (IRB) approvals from the participating clinical sites, expected shortly. The company projects that initial top-line results from this Phase II clinical trial will be available by the summer of 2008, offering a potentially transformative advancement in the treatment landscape for cocaine dependence.
Understanding CPP-109: A Novel Approach to Cocaine Addiction Treatment
CPP-109’s mechanism of action centers around modulating dopamine release in the brain. It functions by inhibiting the enzyme responsible for breaking down gamma-aminobutyric acid (GABA), a neurotransmitter that plays a crucial role in regulating dopamine levels. By increasing GABA availability, CPP-109 helps to dampen the excessive dopamine release triggered by cocaine. Since cocaine and other addictive drugs exert their effects by artificially elevating dopamine levels in brain regions associated with reward and reinforcement, this mechanism is believed to be central to the development of addiction. CPP-109 aims to maintain dopamine levels within a normal range, thereby potentially reducing cravings and the compulsive drug-seeking behavior characteristic of addiction, without disrupting normal dopamine-related brain functions.
Catalyst Pharmaceutical Partners’ interest in CPP-109 is deeply rooted in the encouraging results from two open-label trials conducted in Mexico using vigabatrin, combined with substantial preclinical evidence from the research of Dr. Jonathan Brodie and Dr. Stephen Dewey. These preliminary findings suggest that CPP-109 exhibits a favorable safety profile and holds considerable promise as a treatment for addiction to a range of substances, notably cocaine.
The Widespread Impact of Cocaine Addiction
Cocaine addiction remains a significant global health crisis. Cocaine, a powerfully addictive substance, acts as a potent stimulant on the central nervous system. Its primary effect is to dramatically increase dopamine levels in the brain, leading to intense feelings of euphoria and heightened energy. This surge of dopamine reinforces drug-seeking behavior and drives the cycle of addiction.
Drug abuse and addiction, including cocaine and methamphetamine, pose a massive global health challenge, affecting millions and causing profound social and economic burdens. In the United States alone, the societal costs of drug abuse were estimated at $180 billion in 2002, according to the Office of National Drug Control Policy. Globally, the United Nations Office on Drugs and Crime reported approximately 3.5 million cocaine users and 2.7 million users of amphetamine-type stimulants in Europe in 2004.
Data from the 2005 National Survey on Drug Use and Health in the U.S. indicated that approximately 19.7 million Americans suffered from illicit drug dependence. Cocaine use is alarmingly prevalent, with 33.7 million Americans reporting lifetime cocaine use and 7.9 million reporting crack cocaine use. Current cocaine use was estimated at 2.4 million, with 682,000 using crack cocaine. A staggering 1.5 million individuals were classified as dependent on or abusing cocaine, and approximately 900,000 new cocaine users emerged in 2004. The demand for treatment is evident, with approximately 797,000 individuals seeking treatment for cocaine abuse in 2005.
The same SAMHSA survey highlighted the widespread issue of methamphetamine abuse, with approximately 512,000 monthly users, 192,000 new users in 2004, and 351,000 seeking treatment for methamphetamine and other stimulant abuse in 2005.
Catalyst Pharmaceutical Partners: Dedicated to Addiction Treatment Innovation
Catalyst Pharmaceutical Partners, Inc. is a specialty pharmaceutical company committed to the development and commercialization of innovative prescription drugs for treating addiction. The company holds an exclusive worldwide license from Brookhaven National Laboratory for nine patents and four pending patent applications in the U.S., granting rights to utilize vigabatrin in the treatment of various substance addictions and obsessive-compulsive disorders. These rights extend to foreign patents or patent applications in over 30 countries. CPP-109 is the company’s lead product candidate based on vigabatrin.
The FDA has granted CPP-109 “Fast Track” designation for the treatment of cocaine addiction, recognizing the urgent need for effective treatments for this serious condition and CPP-109’s potential to address unmet medical needs. In May 2007, Catalyst Pharmaceutical Partners announced the successful completion of a bioequivalence study, demonstrating that CPP-109 is bioavailable and bioequivalent to Sabril® Tablets (vigabatrin) marketed in Europe by Sanofi Aventis. This finding potentially links CPP-109 to the extensive existing preclinical and clinical literature on Sabril®. Catalyst Pharmaceutical Partners also planned to initiate a Phase II trial for methamphetamine dependence in the third quarter of 2007, mirroring the design of the cocaine trial, further underscoring their commitment to addressing stimulant addictions.
For further details about Catalyst Pharmaceutical Partners, please contact Patrick J. McEnany, President and CEO, at (305) 529-2522 or visit the company’s website at www.catalystpharma.com.
Forward-Looking Statements
This press release includes forward-looking statements that are subject to risks and uncertainties. Actual results may differ materially from those projected in these statements due to factors such as the timing of IRB approvals, the outcomes of clinical trials, and other risks detailed in Catalyst Pharmaceutical Partners’ filings with the Securities and Exchange Commission (SEC). Investors are encouraged to review the company’s reports filed with the SEC for a comprehensive understanding of these risks. Catalyst Pharmaceutical Partners undertakes no obligation to update this information.
SOURCE: Catalyst Pharmaceutical Partners, Inc.
Tags: addiction, commercialization
