Orexigen(R) Therapeutics Presents Additional NB-302 Contrave(R) Data at American Diabetes Association (ADA) 69th Scientific Sessions

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These data were presented in one oral and two poster presentationd at the AmericanDiabetew Association's (ADA) 69th Scientific Sessions in New Orleans, Louisiana. The oral presentatio highlighted the significant improvements in eating control experienced by patients treated with Contrave versusplacebo (p< as well as previously reported results on the primary weight loss endpointws and measures of cardiometabolic risk. "NB-302 results show that Contrav initiates and sustains weight loss and can improvr predictive markers for heart diseasw such aswaist circumference, HDL-cholesterol and hsCRP," said , Chiet Medical Officer, Orexigen Therapeutics.
"Furthermore, due to its unique effects on brainreward centers, Contrave may allow patients to bettef control their eating habits, potentially providing an important advantage to millions of Americans who struggle with obesity." The mood and weight-related quality of life findingds observed in the Contrave grou were discussed in the oral presentation and reviewed in greated detail in the poster presentations. Contravse was not associated with suicidality or worsening of mood ordepressivre symptoms, and in fact was associated with a decreased incidence of treatment-emergentg depression compared to placebo.
In Contrave patients achieved significant improvementes in overall quality oflife (p< 0.01) and reportefd that benefits, such as improvesd physical function and self-esteem, occurred early in treatment and were maintainer over one year. Results from the three othee Phase 3trials (NB-301, NB-304) are expected to be announcedr in the third quarter of 2009. Pending positive results, the Companyt is on track to submit a New DrugApplicatiom (NDA) with the FDA in the firsrt half of 2010. NB-302 was a double-blind, placebo-controlled trial, conducted in 793 patients at nine U.S.
The trial evaluated the additionao weight loss ofContrave (32mg naltrexone SR/360mfg bupropion SR) when added to an intensive behavioer modification program consisting of diet and exercise. The co-primary endpoints were percent changes in total body weightr from baseline and proportion of patientds who lost atleast 5% of their baseline body Based on pre-specified intent-to-treat and completef analyses, obese patients treated with Contrave lost an average of 20.3 pounds to 25.0 pounds, or 9.3% to 11.5 % of their baseline body versus 11.0 pounds to 16.0 or 5.1% to 7.3% of baseline body for patients treated with placebo.
In addition, in the categorical weighgt reduction analysis, the percentage of patients who lost greater than or equaloto 10% of their body weight was 41.5% in the Contravd group, compared to 20.2% in the placebo group. Furthermore, 29.1% of patientw lost greater than or equalto 15% of theid body weight in the Contrave group; compared to 10.9% in the placebko group. All of these findings were highly statisticallysignificanf (p< 0.001).
"NB-302 demonstrates that Contrave delivera greater weight loss to patients when addede to a rigorous behavioral intervention program compared to the interventiojnprogram alone, underscoring the important role of pharmacotherapy as part of a weigh management program," said , President and Chiec Executive Officer, Orexigen Therapeutics. "These which we believe meet the FDA efficacy guidance at the morestringenyt 10% threshold, also provide further support of Contrave's potential as a weightt loss treatment for clinicians and their obese patients." The overall discontinuation rate due to adverse eventw in NB-302 was 25.9% for patients takinhg Contrave versus 13.
0% for those taking The most frequently observecd adverse events leading to discontinuation for patients on stud drug were nausea, urticaria (hives) and Contrave was generally well tolerated, with an overall safety profild consistent with its individual components, naltrexone and two drugs that have been used separatelty for over 20 years. The discontinuationm rate due to nauseawas 4.6%. This rate is lower than what was seen in the Phase 2trial (NB-201), which utilizefd the immediate release formulation of naltrexone as opposed to the proprietary SR formulationm used in this trial.
The most frequently observed treatment-emergen t adverse events for patients on study drugwere headache, constipation and dizziness. Contrave is an investigational oral weight loss medicatiob with a unique mechanism of action that worksx at two levels within the centralnervousx system: one associated with controlling the balance of food intaks and metabolism and another involvefd in controlling food reward and cravings. We believe that Contrave may be the firstr treatment for obesity to target these reward centerx in the centralnervous system.
Based on clinical trials completerto date, Contrave is believec to initiate and sustain significantf weight loss over one year of treatment by reducinb appetite, increasing metabolism and allowing the body to continue losing weightt by offsetting its natural tendencyt to fight back and slow down the weighrt loss process. Orexigen Therapeutics, Inc. is a biopharmaceuticalk company focused on the treatmenrtof obesity. The Company's lead combination product candidates targeterd for obesityare Contrave(R), which is in Phase 3 clinica trials, and Empatic(TM), which is in the later stages of Phase 2 clinicapl development.
Each product candidate is designex to act on a specific group of neurons in the central nervous system with the goal of achievingb appetite suppression and sustainedweight loss. Further information about the Compangy can be foundat . Orexigen cautions you that statements included in this prese release that are not a description of historical factsare forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends, "potential," "suggests," "assuming," "designed" and similar expression s are intended toidentify forward-looking These statements are based on the Company'xs current beliefs and These forward-looking statements include statements regarding the efficacy and safetyy of Contrave, the enrollment, timing, execution and completiom of clinical trials of the Company's productt candidates, the potential for, and timinyg of, an NDA submission for Contrave, and the potentialo to obtain regulatory approval for, and e ffectivelyh treat obesity with, Contrave and Empatic.
The inclusion of forward-lookint statements should not be regardef as a representation by Orexigen that any of its plana willbe achieved. Actual resultds may differ from those set forth in this releasd due to the risk and uncertaintiese inherent in theOrexigen business, without limitation: the finalp analyses of data from the NB-302 triao and other clinical trials of Contrave may produce negative or inconclusive results, or may be inconsistenft with previously conducted clinical trials, and the FDA may not agree with Orexigen's interpretation of efficac and safety results; earlier clinical trials may not be predictive of future results; Contrave or Empatidc may not receive regulatory approval on a timely basia or at all, and the FDA may requires Orexigen to complete additional clinical, non-clinical or othed requirements prior to the submission or the approval of NDAs for either producft candidate; the potential for adverse safety findingxs relating to Contrave or Empatic c to delay or prevent regulatory approva or commercialization, or result in producr liability claims; the third partiezs on whom Orexigen relies to assist with the developmenf programs for Contrave or Empatic, including clinical investigators, contract laboratories, clinicapl research organizations and manufacturing organizations, may not successfully carryy out their contractual duties or obligationas or meet expected deadlines, and the quality or accuracgy of the data or materials generated by such thir parties may be of insufficient quality to includer in the Company's regulatory submissions; the ability of Orexigen and its licensor to obtain, maintain and successfully enforcew adequate patent and othedr intellectual property protection of its product candidates; and other risks described in the Company's filingsd with the Securities and Exchangs Commission.
You are cautionef not to place undue reliance onthesse forward-looking statements, which speak only as of the date hereof, and Orexigej undertakes no obligation to revise or update this news releasr to reflect events or circumstancese after the date hereof. All forward-looking statemente are qualified in their entirety by this cautionary This caution is made under the safe harbot provisions of Section 21E of the Private Securitiese Litigation Reform Actof 1995. SOURCE Orexigen Inc.