STAMFORD, Conn.–(BUSINESS WIRE)–Purdue Pharma L.P. today announced completion of a Phase 1b dose-ranging study of a novel, potential first-in-class small molecule being investigated for its utility in insomnia associated with alcohol cessation. Following a recent meeting with the US Food and Drug Administration, Purdue is planning to initiate a Phase 2 proof-of-concept (POC) study for this molecule.
“Going forward, with a primary emphasis on internal and partnered research & development programs, we are pursuing new medications to address a variety of unmet needs for patients suffering from some of the most difficult to treat and debilitating conditions, including cancer and select central nervous system disorders,” said Craig Landau, MD, president and CEO, Purdue Pharma. “We are proud of the momentum we have generated in our oncology and central nervous system pipelines and are excited to work toward advancing research that has the potential to improve the lives of patients.”
The Phase 1b randomized, double-blind, cross-over study in subjects with insomnia disorder achieved its primary objective for improved sleep efficiency and secondary objectives for decreased wake time after sleep onset and increased total sleep time as measured by polysomnography, showcasing that the molecule had statistically significant improvement compared to placebo across a range of dose levels (1 mg, 3 mg and 6 mg). The molecule also demonstrated favorable results on measures assessing next-day residual effects.
Subjects with insomnia disorder who were administered this molecule did not experience serious adverse events or discontinuations due to adverse events. Treatment emergent adverse events experienced by two or more subjects in any treatment arm were somnolence, dizziness, headache, and irritability.
“Our initial studies show a clear and exciting dose-effect relationship on sleep promotion in healthy subjects and now in patients with insomnia,” said John Renger, PhD, vice president, Head of Research & Development and Regulatory Affairs, Purdue Pharma. “We are in the midst of completing additional studies to understand this compound’s performance in both alcohol interaction and abuse liability clinical studies.”
Insomnia is a major challenge facing some patients recovering from alcohol use disorder in their struggle to maintain sustained abstinence from alcohol use. Previous studies of patients with alcohol use disorder have found untreated insomnia may interfere with recovery from the alcohol addiction and contribute to relapse during recovery.1
The completion of the Phase 1b and initiation of a Phase 2 POC study of this investigational molecule for insomnia associated with alcohol cessation is the latest example of Purdue’s focus to transform and diversify its therapy portfolio to fulfill unmet needs in healthcare.
Purdue also recently announced an update in its oncology program highlighting the successful completion of a first-in-human Phase 1 dose escalation study of tinostamustine in patients with relapsed or refractory hematological malignancies for which there are no available therapies. The study evaluated the safety and pharmacokinetics, and sought to determine the maximum tolerated dose and inform a Phase 2 dose of tinostamustine.2
This release discusses an investigational new drug under development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that such investigational drug will successfully complete clinical development or receive regulatory approval.
About Purdue Pharma
Purdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications and technologies through internal research & development and strategic industry partnerships. For more information, please visit www.purduepharma.com.
1. Arnedt JT, Conroy DA, Brower KJ. Treatment options for sleep disturbances during alcohol recovery. J Addict Dis. 2007; 26(4):41-54.
2. Information about the tinostamustine dose escalation study can be accessed at this link or ClinicalTrials.gov, identifier: NCT02576496.