Juniper Pharmaceuticals Reports Results from Phase 2b Clinical Trial of COL-1077 Lidocaine Vaginal Gel in Gynecologic Procedure Pain
PRNewswire: August 17, 2016 – BOSTON, MA, U.S.A. – Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) (“Juniper” or the “company”), a women’s health therapeutics company, today announced that a recently completed phase 2b clinical trial evaluating its 10% lidocaine bioadhesive vaginal gel, COL-1077, for the reduction of pain intensity in women undergoing an endometrial biopsy with tenaculum placement did not achieve its primary and secondary endpoints. The safety and pharmacokinetic (PK) profiles of COL-1077 were consistent with what has been observed in prior clinical trials of the lidocaine bioadhesive vaginal gel.
“We are disappointed that COL-1077 did not achieve the desired effect in this clinical trial. We believe the study was well-designed and -conducted and has adequately tested our hypothesis,” said Dr. Bridget A. Martell, Juniper’s chief medical officer. “On behalf of the Juniper team, I want to thank the patients and investigators who participated in this study.”
“Based on the results of this trial, we are discontinuing development of COL-1077,” said Alicia Secor, chief executive officer. “We will focus Juniper’s resources on our differentiated intravaginal ring (IVR) technology to advance our pipeline of product candidates to address unmet needs in women’s health.”
Juniper’s IVR programs are led by JNP-0101, an investigational oxybutynin IVR for the treatment of overactive bladder (OAB) in women. Roughly nine million women receive pharmacotherapy for this chronic condition in the United States alone. IND-enabling animal PK studies are underway, and the company expects pilot study results later this year.
“We expect to fund our operations and planned R&D activities with cash flows generated by our core business. We expect ongoing strong performance from the Crinone® franchise and Juniper Pharma Services,” Ms. Secor added.
“We remain committed to delivering value-added treatments that meet the unique and underserved healthcare needs of women,” Ms. Secor concluded.
Juniper Pharmaceuticals, Inc., is focused on developing therapeutics that address unmet medical needs in women’s health. The company is advancing a pipeline of proprietary product candidates that leverage novel intravaginal drug delivery technologies and the 505(b)(2) regulatory pathway. Juniper’s core operating business includes the Crinone® (progesterone gel) franchise and Juniper Pharma Services, which provides high-end fee-for-service pharmaceutical development and clinical trials manufacturing to clients. Please visit www.juniperpharma.com for more information.
Juniper Pharmaceuticals™ is a trademark of Juniper Pharmaceuticals, Inc., in the United States and European Union.
Crinone® is a registered trademark of Merck KGaA, Darmstadt, Germany, outside the United States and of Allergan, Inc., in the United States.
