Camargo Congratulates US WorldMeds on Obtaining FDA Approval for the First Non-Opioid Medicine for the Management of Opioid Withdrawal Symptoms
Published: Jul 09, 2018
CINCINNATI, July 9, 2018 /PRNewswire/ -- Camargo Pharmaceutical Services, LLC, ("Camargo"), the global development and commercialization partner and industry leader utilizing the FDA 505(b)(2) pathway, congratulates US WorldMeds, LLC, on obtaining US Food and Drug Administration (FDA) approval for LUCEMYRA™ (lofexidine) tablets, the first and only non-opioid medication indicated for mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults.
US WorldMeds partnered with Camargo for regulatory support and expertise in developing this innovative approach to managing opioid withdrawal symptoms. On May 16, 2018, the FDA approved the first non-opioid medication, LUCEMYRA, targeted specifically to treat the physical symptoms associated with opioid withdrawal. Camargo supported US WorldMeds with drug development services, especially Chemistry, Manufacturing, and Controls (CMC) and regulatory consulting services.
"Camargo is pleased to have supported US WorldMeds in the development of this important therapy intended to avoid or lessen the effects of opioid withdrawal," said Dr. Ruth Stevens, Camargo Pharmaceutical Services Chief Scientific Officer and Co-Founder. "Camargo shares US WorldMeds' vision to improve the lives of patients in need, including those living with physical opioid dependence and addiction, and we look forward to continuing work with US WorldMeds as they develop programs to benefit patients."
"We appreciate the guidance and insights provided by Camargo," said Kristen Gullo, Vice President, Development and Regulatory Affairs at US WorldMeds. "Our collaboration helped us advance the development program to NDA submission, allowing us to bring this important medication to people in need of help to overcome opioid withdrawal."
ABOUT CAMARGO PHARMACEUTICAL SERVICES, LLC.
Camargo Pharmaceutical Services is the global development and commercialization partner with a proven ability to help bring life-changing therapies to the market faster and more cost-effectively. Founded in 2003, the company offers a full portfolio of pharmaceutical services from concept through commercialization to improve medicines.
Camargo has emerged as one of the recognized experts and industry leaders utilizing the FDA 505(b)(2) approval pathway. The company is passionate about the client's success and the differences we can make in the lives of others. Camargo's global reach and client base extends to more than 25 countries.
Camargo is headquartered in Cincinnati, Ohio. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com.
ABOUT US WORLDMEDS, LLC.
US WorldMeds is a specialty pharmaceutical company whose treatment options are making a difference in the lives of the patients and communities it serves. US WorldMeds takes an agile and personal approach to pharmaceuticals - pioneering research and product development in therapeutic areas that desperately need new solutions. Headquartered in Louisville, Kentucky, US WorldMeds has global presence and more than 15 years of experience in the development, licensure, and commercialization of unique products. For more information about US WorldMeds, visit http://www.usworldmeds.com/.
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SOURCE Camargo Pharmaceutical Services, LLC