New PDUFA action date for Brixadi set for 15 December 2021
LUND, Sweden, June 26, 2021 /PRNewswire/ -- Camurus (NASDAQ
STO: CAMX) announced today that the New Drug Application (NDA) by
Camurus' US licensee Braeburn for Brixadi™ (buprenorphine)
extended-release weekly and monthly injection for subcutaneous use
for moderate to severe opioid use disorder was accepted for review
by the US Food and Drug Administration (FDA). The Prescription Drug
User Fee Act (PDUFA) action date is set for 15 December 2021.
"We are pleased that the FDA has accepted Braeburn's updated new
drug application for Brixadi. We now look forward to the NDA
approval and our innovative treatment finally becoming available to
US patients with opioid use disorder," says Fredrik Tiberg, President and CEO of Camurus.
"The opioid crisis has worsened during the Covid-19 pandemic and
there is a significant need for new and effective treatments."
The resubmission is in response to the Complete Response Letter
(CRL) issued by the FDA to Braeburn on 1
December 2020 citing deficiencies identified during a
pre-approval inspection of Braeburn's third-party manufacturer in
the US.
For more information
Fredrik Tiberg, President &
CEO
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com
Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
ir@camurus.com
About Brixadi
Brixadi is an investigational, extended-release weekly (8mg,
16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injection for
subcutaneous use that is under review by FDA for the treatment of
moderate to severe opioid use disorder in patients who have
initiated treatment with a single dose of a transmucosal
buprenorphine product or who are already being treated with
buprenorphine. If approved, Brixadi would be used as part of a
complete treatment plan to include counseling and psychosocial
support. Brixadi will be available through a Risk Evaluation and
Mitigation Strategy (REMS) program and administered only by
healthcare providers in a healthcare setting.
During the clinical development program, the safety profile
of Brixadi was generally consistent with the known safety profile
of oral buprenorphine with the exception of mild-to-moderate
injection-site reactions. The most common adverse reactions
(occurring in ≥5% of patients) associated with Brixadi
administration included injection-site pain, headache,
constipation, nausea, injection-site erythema, injection-site
pruritus, insomnia and urinary tract infections.
Brixadi™ is the US trademark for Camurus' product
Buvidal® approved for treatment of opioid
dependence in the EU, UK, Australia, Switzerland and New
Zealand.
About Camurus
Camurus is a Swedish science-led biopharmaceutical company
committed to developing and commercialising innovative and
differentiated medicines for the treatment of severe and chronic
conditions. New drug products with best-in-class potential are
conceived based on the company's proprietary
FluidCrystal® drug delivery technologies and its
extensive R&D expertise. Camurus' clinical pipeline includes
products for the treatment of cancer, endocrine diseases, pain and
addiction, which are developed in-house and in collaboration with
international pharmaceutical companies. The company's shares are
listed on Nasdaq Stockholm under the ticker CAMX. For more
information, visit www.camurus.com .
This information is information that Camurus AB is obliged to
make public pursuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of
the managing director, at 4:00 pm CET
on 26 June 2021.
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