Navigation Links
Catalyst Pharmaceutical Partners, Inc. Announces Top-Line Results,of Its Bioequivalence Study of CPP-109 (Vigabatrin), the Company's,Investigational Drug to Treat Cocaine and Methamphetamine Addiction

CORAL GABLES, Fla., May 09, 2007 /PRNewswire-FirstCall/ -- Catalyst Pharmaceutical Partners, Inc. announced today positive initial, top-line results from a bioequivalence study demonstrating that CPP-109 (Catalyst's Vigabatrin Tablets) is bioavailable and bioequivalent to Sabril Tablets, the version of vigabatrin marketed in Europe by Sanofi Aventis. These data potentially provide a basis for linking CPP-109 to the extensive body of published pre-clinical and clinical literature on Sabril.

Vigabatrin has been marketed over the past decade in more than 30 countries under the brand name Sabril(R) as a secondary treatment for adult epilepsy and as a primary treatment for the management of infantile spasms, known as West Syndrome.

Commenting on today's news and the Company's product development program, Patrick J. McEnany, Catalyst's Chairman and Chief Executive Officer, stated, "We are encouraged by the initial, top-line results of our bioequivalence study and look forward to moving ahead with our U.S. Phase II clinical trials evaluating the use of CPP-109 for the treatment of cocaine addiction and methamphetamine addiction. The CPP-109 tablets required for our upcoming clinical trials have been formulated and manufactured and are now available for our use. We expect to commence our U.S. Phase II clinical trial with respect to cocaine addiction in the second quarter of 2007 and our U.S. Phase II clinical trial with respect to methamphetamine addiction in the third quarter of 2007."

About The Bioequivalence Study

In the bioequivalence study, investigators randomized 30 healthy male and female subjects to either of two treatments -- a 500 mg. tablet of Sabril(R) or 500 mg. tablet of CPP-109. The researchers dispensed the assigned medication tablet to the participants after an overnight fast and collected blood plasma samples before dosing. An additional 21 blood plasma samples were collec ted after dosing over a period of 36 hours. After a washout period of eight days, each participant was crossed over to receive the alternate tablet, and plasma samples were collected according to the same schedule. A total of 28 subjects completed both arms of the study. This study was conducted as recommended by the Food and Drug Administration's Guidance for Industry, "Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations."

Bioequivalence of the two tablet formulations is supported by the pharmacokinetic data collected for CPP-109 and Sabril(R). Specifically, the maximum plasma concentration and area under the curve for vigabatrin were similar for CPP-109 and Sabril(R) Tablets. The 90% geometric confidence intervals attained for these pharmacokinetic parameters were well within the 80% to 125% range recommended by the Food and Drug Administration's Guidance for Industry, "Statistical Approaches to Establishing Bioequivalence," and the two products meet the requirements to be considered bioequivalent.

About Catalyst Pharmaceutical Partners

Catalyst Pharmaceutical Partners is a specialty pharmaceutical company focused on the development and commercialization of prescription drugs for the treatment of addiction. The Company has obtained from Brookhaven National Laboratory an exclusive worldwide license for nine patents and four patents pending in the United States relating to the right to use vigabatrin to treat a wide variety of substance addictions. Catalyst has also been granted rights to Brookhaven's vigabatrin-related foreign patents or patents pending in more than 30 countries. The Company's initial product candidate based on vigabatrin is CPP-109. CPP-109 has been granted "Fast Track" status by the U.S. Food & Drug Administration (FDA) for the treatment of cocaine addiction. This indicates that the FDA has recognized that CPP-109 is intended for the treatment of a serious or life-thre atening condition for which there is no effective treatment and which demonstrates the potential to address unmet medical needs. For more information about the Company, go to

This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties which may cause the Company's actual results in future periods to differ materially from forecasted results. A number of factors, including that the final results of our bioequivalence study will be consistent with the top-line results received to date and those described in the Annual Report on Form 10-K that the Company has filed with the U.S. Securities and Exchange Commission ("SEC") reporting its financial position and results of operations as of and for the year ended December 31, 2006, could adversely affect the Company's ability to obtain these results. Copies of the Company's filings with the SEC are available from the SEC or may be obtained upon request from the Company. The Company does not undertake any obligation to update the information contained herein, which speaks only as of this date.

CONTACT: Patrick J. McEnany, Chief Executive Officer, +1-305-529-2522,, or Jack Weinstein, Chief Financial Officer,+1-201-934-4201, , both of CatalystPharmaceutical Partners; media, Tina Posterli, Rx Communications Group,+1-917-322-2565,

Web site:

Ticker Symbol: (NASDAQ-NMS:CPRX)

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All ri ghts reserved.
A United Business Media Company


Related medicine technology :

1. Materia Licenses Metathesis Catalyst Platform to Eisai
2. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
3. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
4. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
5. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
6. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
7. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
8. Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings
9. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
10. Portola Pharmaceuticals Announces Positive Phase II EXPERT Results and Additional Oral and Poster Presentations at the XXI Congress of the International Society on Thrombosis and Haemostasis (ISTH)
11. Cyclacel Pharmaceuticals Announces Results of Phase II Seliciclib Combination Studies
Post Your Comments:
(Date:11/25/2015)... WILMINGTON, N.C. , Nov. 25, 2015 /PRNewswire/ ... announces the planned investment of at least $15.8 ... in Wilmington, NC . The ... services capacity to meet the growing demands of ... Wilmington site expansion will provide up ...
(Date:11/25/2015)... , Nov. 25, 2015 Allergan plc (NYSE: ... agreement with the New York State ... of the Sherman Act, and other statutes with the Attorney ... February 2014, to cease marketing and selling the now generic ... settlement, Allergan admits no liability, has released its counterclaims against ...
(Date:11/25/2015)... USP 800 applies to all healthcare ... pharmacy technicians, nurses, physicians, physician assistants, home healthcare ... covers all entities which store, prepare, transport, or ... institutions, patient treatment clinics, physicians, practice facilities, and ... --> What is the purpose of USP ...
Breaking Medicine Technology:
(Date:11/26/2015)... ... November 26, 2015 , ... Somu Sivaramakrishnan announced today ... owner, Somu now offers travelers, value and care based Travel Services, including exclusive ... as well as, cabin upgrades and special amenities such as, shore excursions, discounted ...
(Date:11/26/2015)... , ... November 26, 2015 , ... ... set of retro-fused, self-animating trailer titles with ProTrailer: Vintage. This newly styled ProTrailer ... classically-influenced trailer titles work with any font, giving users limitless opportunities to stylize ...
(Date:11/25/2015)... ... 2015 , ... The holiday season is jam-packed with family ... of attendees is of the utmost importance. Whether you are cooking at home ... recipes a try this holiday season. , Turkey Croquettes ,     Ingredients: ...
(Date:11/25/2015)... ... November 26, 2015 , ... Ministers, senior ... (EU), ANDI Pan African Centres of Excellence, and public R&D institutions, civil societies ... the opening of the 5th African Network for Drugs and Diagnostics Innovation, ANDI, ...
(Date:11/25/2015)... ... November 25, 2015 , ... Dental professionals who would like ... , are invited to attend Dr. Mark Iacobelli’s Advanced Implant Mentoring (AIM) CE course. ... OH. , As the co-founders of Advanced Implant Mentoring (AIM), Dr. Iacobelli and ...
Breaking Medicine News(10 mins):