Market Overview

Purdue Pharma L.P. Advances Its Pipeline with Novel, Potential First-in-Class Small Molecule for Insomnia Associated with Alcohol Cessation


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

"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

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
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


1. Arnedt JT, Conroy DA, Brower KJ. Treatment options for sleep
disturbances during alcohol recovery. J Addict Dis. 2007;

2. Information about the tinostamustine dose escalation study can be
accessed at this
 or, identifier: NCT02576496.

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