Currax Pharmaceuticals Granted Type C Meeting with FDA Regarding its Phase 3 Study to Evaluate the Safety and Efficacy of CX-101
Phase 3 Study will evaluate CX-101 for the indication of smoking cessation
BRENTWOOD, TN, October 21, 2021 — Currax Pharmaceuticals LLC (“Currax”), a specialty biopharmaceutical company dedicated to expanding access to clinically differentiated, underappreciated medicines – both branded and generic – today announced it has a Type C written response meeting with the U.S. Food and Drug Administration (“FDA”) regarding a New Drug Application for a Phase 3 program to evaluate the safety and efficacy of CX-101 (naltrexone HCl/bupropion HCl 8 mg/90 mg, extended-release tablets), for the indication of smoking cessation.
The Phase 3 program builds on the successful Phase 2b findings and evaluates a mixed-weight population at a fixed-dose combination of CX-101 (naltrexone/bupropion 32 mg/360 mg total daily dose). The Phase 3 program evaluates a broader set of factors, including weight gain, that often deter patients from pursuing smoking cessation treatments. Currax will support the Phase 3 program participants with both telephonic and mobile counseling.
“There is a growing need for treatment options to help patients who are struggling to quit smoking,” said Currax Pharmaceuticals President and CEO, George Hampton. “While the last 15 years have seen tremendous innovation from tobacco companies, there has been limited innovation on smoking cessation treatments.” Smoking costs the U.S. healthcare system $170 billion annually and an additional $156 billion is Iost each year from the impact of reduced productivity and exposure to second-hand smoke. CX-101 is an investigational drug being studied for smoking cessation.
About Currax Pharmaceuticals LLC
Currax Pharmaceuticals LLC is a specialty pharmaceutical business focused on acquiring and commercializing prescription Medicines worldwide. Currax distributes a range of both branded and generic pharmaceutical products, including CONTRAVE® (naltrexone HCl/bupropion HCl), ONZETRA® Xsail® (sumatriptan nasal powder), Silenor® (doxepin), Treximet®, (sumatriptan/naproxen sodium), and the authorized generic of Treximet®. For more information, please visit www.curraxpharma.com.
Edelman Financial Communications & Capital Markets