Sunovion Pharmaceuticals Inc.Patricia Moriarty, 508-787-4279Senior Director Corporate Communications
Sunovion Pharmaceuticals Inc. (Sunovion) announced today that it has met the United States Food and Drug Administration (FDA) requirements for pediatric exclusivity for LUNESTA(eszopiclone), a prescription sleep medicine used in adults for the treatment of insomnia. Sunovion has now gained an additional six months of United States market exclusivity for LUNESTA, which will expire on May 31, 2014.
The approval of pediatric exclusivity does not mean that LUNESTA is approved for use in pediatric patients. LUNESTA is FDA approved only for use in adults with insomnia aged 18 and older. Based on study results, Sunovion will not be seeking a pediatric indication for LUNESTA.
Lunesta(eszopiclone) is a prescription sleep medicine used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include trouble falling asleep and waking up often during the night.
LUNESTA acts quickly, so take it right before bed, and only if you have 8 hours to devote to sleep. Until you know how you will react to LUNESTA, you should not drive or operate machinery. Call your healthcare professional if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems. Walking, eating, driving, or engaging in other activities while asleep without remembering it the next day have been reported. Other abnormal behaviors include aggressiveness, agitation, hallucinations, and confusion. In depressed patients, worsening of depression including risk of suicide may occur. These risks may increase if you drink alcohol. Severe allergic reactions such as swelling of the tongue and throat occur rarely and may be fatal. Call your healthcare professional if you experience these or any effects or reactions that concern you. LUNESTA, like most sleep medicines, carries some risk of dependency. Side effects may include unpleasant taste, headache, morning drowsiness, and dizziness. For more information, please see the .
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. The products discussed herein may have different product labeling in different countries. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient. Remember that no medicine is for everyone. Only your healthcare professional can prescribe LUNESTA for you.
Sunovion is a leading pharmaceutical company dedicated to discovering, developing and commercializing therapeutic products that advance the science of medicine in the central nervous system (CNS) and respiratory disease areas and improve the lives of patients and their families. Sunovion's drug development program, together with its corporate development and licensing efforts, has yielded a portfolio of pharmaceutical products including LATUDA(lurasidone HCl) tablets, LUNESTA (eszopiclone) tablets, XOPENEX (levalbuterol HCI) inhalation solution, XOPENEX HFA (levalbuterol tartrate) inhalation aerosol, BROVANA (arformoterol tartrate) inhalation solution, OMNARIS (ciclesonide) nasal spray, ZETONNA™ (ciclesonide) nasal aerosol and ALVESCO(ciclesonide) inhalation aerosol.
Sunovion, an indirect, wholly-owned subsidiary of Dainippon Sumitomo Pharma Co., Ltd., is headquartered in Marlborough, Mass. More information about Sunovion Pharmaceuticals Inc. is available at .
DSP is a multi-billion dollar, top-ten listed pharmaceutical company in Japan with a diverse portfolio of pharmaceutical, animal health and food and specialty products. DSP aims to produce innovative pharmaceutical products in the CNS field, which has been designated as the key therapeutic area and will also focus in on other specialty disease categories with significant unmet medical needs, which are designated as frontier therapeutic areas. DSP is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, DSP has more than 7,000 employees worldwide. Additional information about DSP is available through its corporate website at .
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. 2012 Sunovion Pharmaceuticals Inc.
LATUDAis a registered trademark of Dainippon Sumitomo Pharma Co., Ltd. LUNESTA, XOPENEX, XOPENEX HFA and BROVANA are registered trademarks and ZETONNA is a trademark of Sunovion Pharmaceuticals Inc. OMNARIS and ALVESCO are registered trademarks of Nycomed GmbH, used with permission.
For a copy of this release or any recent release, visit Sunovion's website at .