The Light Study, a Long-Term Research Study of Investigational Weight Loss Drug Contrave®, Begins Enrolling Patients Nationwide
SAN DIEGO, June 6, 2012 /PRNewswire/ — Orexigen® Therapeutics, Inc. (Nasdaq: OREX) today announced that the Light Study, a long-term research study of Contrave® (naltrexone SR/bupropion SR), a new, investigational drug being evaluated for weight loss, has begun enrolling patients at clinical sites throughout the United States. The Light Study is designed to assess the cardiovascular health outcomes of Contrave.
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Nearly 93 million Americans are affected by obesity, and that number is predicted to increase to 120 million Americans within the next five years.[i] More than one-third of adults in the United States are affected by obesity[ii]. Obesity increases the risk of heart disease, type 2 diabetes, some types of cancer, sleep apnea, and a variety of other conditions. Medical research suggests that losing just five percent of your body weight can significantly improve your health and reduce the risk of complications from type 2 diabetes and heart disease.[iii],[iv]
“We need new alternatives to fight the growing obesity epidemic in the United States,” said Steven E. Nissen, M.D., Lead Investigator of the Light Study and Chairman of the Robert and Suzanne Tomsich Department of Cardiovascular Medicine at the Cleveland Clinic.[v] “One critical test of any weight loss treatment is its impact on cardiovascular health. The Light Study uses an innovative design that focuses on determining the safety and effectiveness of Contrave in patients who actually lose weight during treatment. This approach simulates how weight loss drugs are used in clinical practice. We think this trial design is a potentially important innovation in the development of new obesity therapies because it is sufficiently rigorous for regulatory authorities and feasible for drug developers, while also incorporating specific elements to help protect the safety of patients.”
“Most people cannot achieve long term weight loss by diet and exercise alone,” said Steven R. Smith, M.D., Professor and Scientific Director of The Florida Hospital – Sanford-Burnham Translational Research Institute for Metabolism and Diabetes. “The Light Study is an important clinical research study evaluating the cardiovascular health outcomes of Contrave, which is designed to reduce appetite, increase metabolism, and control cravings and overeating behaviors.”
In an effort to raise awareness of the obesity epidemic, the potential need for new and diverse treatment options, the benefits of reducing weight to improve certain measures of health and well being, and the Light Study, the Obesity Action Coalition (OAC) has partnered with Orexigen to launch the “Take Five to Live Light” campaign. The campaign encourages those affected by obesity to take five minutes to learn how losing just 5 percent of their weight can benefit cardiovascular health and to take five minutes to get screened for the Light Study. Individuals interested in participating in the Light Study can visit www.lightstudy.com to see if they qualify.
“We are proud to join forces with the OAC to educate the millions of Americans affected by obesity about the health benefits of weight loss,” said Michael Narachi, President and Chief Executive Officer of Orexigen. “The OAC is a strong voice for those affected by obesity and an important partner in the fight against this epidemic. We encourage those who are interested in joining this cause to consider becoming a member of the OAC.”
“The disease of obesity is extremely complex and requires a multidisciplinary team approach to treat it,” said Joe Nadglowski, OAC President and CEO. “Many individuals affected by the disease of obesity need access to safe and effective treatment options; however, options are currently limited and new weight-loss management approaches are desperately needed. The OAC is excited to work with Orexigen to support obesity research for safe and effective options through the Light Study. This type of research is imperative in order to offer individuals affected by obesity valid, safe and effective tools to combat their weight and increase their quality of health.”
Individuals may qualify for the Light Study if they are men age 45 or older or women age 50 or older; need to lose weight; and have a cardiovascular risk factor, such as heart disease or type 2 diabetes with certain heart risk factors.
In addition to the potential to receive Contrave, all who qualify and choose to participate in the Light Study will be part of an innovative, comprehensive weight management program called WeightMate(TM). Delivered through an internet-based platform by accredited health and fitness professionals, WeightMate provides a convenient, progressive nutrition and exercise program with goal setting and tracking tools. WeightMate is powered by Sharecare®, an interactive health and wellness social platform providing people with access to expert-developed answers, information and programs to live their healthiest life. Sharecare was created by Jeff Arnold, the founder of WebMD, and Dr. Mehmet Oz of “The Dr. Oz Show”, to connect individuals with health experts and simplify the search for high-quality healthcare information.
“The Light Study is truly an innovative clinical trial, and we are honored to be working with such a high caliber team of advisors and partners in its execution,” Narachi said. “We are committed to enrolling the Light Study expeditiously so that we have the opportunity to resubmit the Contrave New Drug Application for review by the United States Food and Drug Administration as early as possible.”
Contrave (naltrexone SR/bupropion SR) is an investigational medication being evaluated for weight loss. Contrave has been studied to date in clinical trials enrolling more than 4,500 people and was developed by Orexigen to reduce appetite, help control cravings, increase metabolism and improve control over eating behaviors. Contrave has been shown to help people lose weight and keep it off for up to one year. In previous clinical trials, 53 percent of study participants taking Contrave and 21 percent of those taking placebo lost five percent or more of their body weight over the 12 month trial duration. Those who took Contrave for six months, combined with a structured weight management program, lost an average of 25 pounds, compared with 17 pounds for those using the weight management program and receiving placebo. Many patients saw noticeable improvements in cholesterol levels, and blood sugar control, as well as smaller waistlines. Those who combined Contrave with diet and exercise experienced the most reduction in body weight. There is no guarantee that Contrave will make patients lose weight.
Contrave was generally well tolerated in clinical trials. In the Contrave clinical development program, the most frequent adverse events on Contrave were nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea. These were mostly mild to moderate in severity and did not last long.
WeightMate(TM) is a comprehensive weight management program developed for the Light Study through a partnership between Orexigen and Sharecare, an interactive social, Q&A platform created by Jeff Arnold and Dr. Mehmet Oz in partnership with Harpo Studios, Remark Media, Sony Pictures Television and Discovery Communications. Delivered through an internet-based platform by accredited health and fitness professionals, WeightMate provides a convenient, progressive nutrition and exercise program with goal setting and tracking tools to help users achieve their health goals.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company’s lead product candidate is Contrave, which has completed Phase III clinical trials and for which a New Drug Application has been submitted and reviewed by the FDA. The Company has also reached agreement with the FDA on a Special Protocol Assessment (SPA) for the Light Study, the Contrave cardiovascular outcomes trial. The Company’s other product candidate, Empatic(TM), has completed Phase II clinical trials. Further information about the Company can be found at www.orexigen.com.
About the Obesity Action Coalition (OAC)
The OAC is the only non-profit organization whose sole focus is representing individuals affected by obesity. Founded in 2005, the OAC remains at the forefront of the fight against obesity. From advocating on capitol hill for access to obesity treatments to publishing hundreds of educational resources for individuals affected, the OAC truly represents the voice of all those affected by obesity. For more information on the OAC, please visit www.obesityaction.org.
Orexigen Forward-Looking Statements
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding the Light Study; the safety and effectiveness of Contrave; the ability and speed of patient enrollment in the Light Study; the potential for, and timing of, the accrual of MACE events and the potential resubmission of the Contrave NDA; and the potential for, and timing of, approval for Contrave. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the Special Protocol Assessment (SPA) is not binding on the FDA if public health concerns unrecognized at the time the SPA agreement was entered into become evident, other new scientific concerns regarding product safety or efficacy arise, or if Orexigen fails to comply with the agreed upon trial protocol; Orexigen’s ability to conduct the Light Study and the progress and timing thereof; Orexigen’s ability to demonstrate in the Light Study that the risk of MACE in overweight and obese subjects treated with Contrave does not adversely affect the product candidate’s benefit-risk profile; the potential that earlier clinical trials may not be predictive of future results in the Light Study; the potential for the FDA to not approve Contrave even after the resubmission with the MACE event data; the potential for early termination of the collaboration agreement between Orexigen and Takeda; the costs and time required to complete additional clinical, non-clinical or other requirements prior to any resubmission of an NDA; the therapeutic and commercial value of Contrave; Orexigen’s ability to maintain sufficient capital; and other risks described in the Company’s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in Orexigen’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission May 10, 2012 and which is available from the SEC’s website (www.sec.gov) and on Orexigen’s website (www.orexigen.com) under the heading “Investor Relations.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
[i] Understanding obesity: an educational resource provided by the Obesity Action Coalition. Obesity Action Coalition. Available at http://www.obesityaction.org/wp-content/uploads/Understanding_Obesity.pdf. Accessed on April 4, 2012.
[ii] Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of obesity in the United States, 2009-2010. NCHS data brief, no 82. Hyattsville, MD: National Center for Health Statistics. 2012.
[iii] Wing RR, Lang W, Wadden TA, et al. Benefits of modest weight loss in improving cardiovascular risk factors in overweight and obese individuals with type 2 diabetes. Diabetes Care. 2011 Jul;34(7):1481-6.
[iv] Williamson DF, Thompson TJ, Thun M, et al. Intentional weight loss and mortality among overweight individuals with diabetes. Diabetes Care. 2000 Oct;23(10):1499-504.
[v] Dr. Nissen has no financial relationship with Orexigen.
SOURCE Orexigen; Obesity Action Coalition