AUCKLAND, New Zealand, June 24,
2024 /PRNewswire/ -- Douglas Pharmaceuticals,
New Zealand's largest
pharmaceutical company, is pleased to announce that results from
their recent trial, "Randomised Placebo-Controlled Phase 2 Study of
Extended-Release Ketamine Tablets (R-107) for Treatment-Resistant
Depression", also known as the BEDROC study, have just been
published by the leading scientific journal Nature
Medicine.
Douglas Pharmaceuticals' Chief Scientific Officer, Dr
Peter Surman, commented, "We're
pleased that the quality and design of the study, as well as the
significance of the findings have been recognised and are now being
shared with industry peers. Should R-107 perform in Phase 3 studies
as in the BEDROC study this would be a life-changing medication for
many individuals who suffer from Treatment-Resistant Depression
(TRD), and one that could be taken safely at-home."
The BEDROC study enrolled patients with TRD who had failed
two or more antidepressants in the current period of depression.
Patients responded rapidly to R-107 during the daily dose induction
phase of BEDROC and around 73% (168/231) of patients were
responders after 1 week. This response rate is comparable to
results achieved with off-label IV ketamine treated TRD patients
but without undesirable dissociation (spacing out). R-107 shows
promise to be a rapid acting, convenient and accessible form of
ketamine.
Dr Surman acknowledged the valuable contributions made by
Douglas' Product Development Team, the investigators involved, and
Professor Paul Glue, MD, University
of Otago, Hazel Buckland Professor, Chair of the Trial Steering
Committee for BEDROC. Professor Glue has worked closely with
Douglas as a consultant and serves as the Clinical Advisory Board
Chair for R-107. With over 20 years of pharmaceutical experience,
Professor Glue specialises in mood disorder research, including the
use of ketamine for TRD.
Professor Glue commented, "The BEDROC study shows that it is
possible to achieve a robust anti-depressant response from ketamine
without significant dissociation. We saw a clear dose response
effect over 3 months and met the primary efficacy endpoint at Day
92 with significant separation from placebo in the 180 mg dose arm.
This gives us confidence to proceed to pivotal registrational
clinical studies."
The results of the BEDROC study revealed that R-107 was well
tolerated, and this was confirmed by the follow-up 6 months
open-label study BEDROC-1. Most adverse events (AEs) were
mild with no safety signals encountered. Dissociation and sedation
AEs when administering ketamine or esketamine (one of the active
components of ketamine) from rapid releasing dosage forms such as
intranasal esketamine (56, 84 mg) are so significant that the
product must be administered in a clinic with an observation period
of at least 90 minutes after dosing. In the BEDROC
study, dissociation and sedation AEs were mild and patients
took R-107 at home without any safety issues.
Upon completing up to 9 months of treatment on R-107 in BEDROC
and BEDROC-1 a significant portion of patients (106) were enrolled
in a compassionate use program where the mean duration of treatment
is currently 2 years. Most patients have continued to be treated
with 180 mg of R-107 twice a week.
The peer-reviewed full manuscript can be accessed here:
https://www.nature.com/articles/s41591-024-03063-x
For further information, please contact:
Lisa Craigie
Chief Legal & Commercial Officer
Douglas Pharmaceuticals
Email: lisac@douglas.co.nz
About Treatment Resistant Depression
About 60 million patients in the United States and
Europe suffer from Major Depressive Disorder (MDD).
Roughly one third of MDD patients are classified as
being treatment resistant, in that they have failed two or
more antidepressants in the current period of depression.
About R-107
R-107 is a proprietary, extended-release oral dose of ketamine
developed for the treatment of patients with TRD. After
administration the active ingredient ketamine is released at a
slow, steady rate. The reduction in dissociative side effects is
attributed to a low systemic concentration of ketamine. An IND is
open with the US FDA for all studies needed to support a regulatory
submission. Douglas is open to meeting potential partners and
investors interested in collaborating to complete the Phase 3
development of R-107 and prepare it for commercialisation.
For more information, please visit: A world-first at home
treatment for Treatment Resistant Depression - R-107 on Vimeo
About Douglas Pharmaceuticals
Douglas Pharmaceuticals is a privately held pharmaceutical
company headquartered in Auckland,
New Zealand. Douglas Pharmaceuticals is a developer and
manufacturer of generic and repurposed medicines sold in the US,
Europe and in over 40 markets
globally. The Douglas mission is to 'Improve Lives' by providing
innovative, competitive, and high-quality healthcare solutions.
Douglas' core business is producing prescription drugs for areas
including oncology, dermatology, the central nervous system, and
immunology. Douglas develops, manufactures, and distributes novel
and generic products, with a preference for those where there is a
strong intellectual property position as well as technical
complexity in areas of high unmet need.
For more information, please visit: www.douglas.co.nz
About Nature Medicine
Nature Medicine is a world-leading, peer-reviewed scientific
journal that covers all aspects of research related to medicine.
The journal has a 2022 2-year impact factor of 82.9.
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SOURCE Douglas Pharmaceuticals Ltd