FDA ordered to reconsider, with deliberate speed, Braeburn's
application for final approval of Brixadi™
LUND, Sweden, July 23, 2019 /PRNewswire/ -- Camurus AB
(NASDAQ STO: CAMX) today announces that the United States District Court for the
District of Columbia grants
Braeburn's motion for summary judgement, vacating the U.S. Food and
Drug Administration's (FDA) decision to block final market approval
of Brixadi™ Monthly. The court rules that, in December 2018, the FDA acted inconsistently with
precedent by delaying the approval of Brixadi™ and granting a
three-year exclusivity to Sublocade™. The case is remanded to the
FDA to reconsider, with deliberate speed, Braeburn's application
for final approval of Brixadi™ Monthly.
"The court's decision is highly important to Camurus, both
commercially and in principle. We look forward to seeing the FDA
act with deliberate speed in accordance with the court's decision,
to give US patients earlier access to Brixadi™ and thereby
contributing to reducing the detrimental impacts of the ongoing
opioid crisis," says Fredrik Tiberg,
CEO and Head of R&D of Camurus.
On 21 December 2018, the FDA
issued Braeburn a tentative approval of Brixadi™ for the treatment
of moderate-to-severe opioid use disorder (OUD) in patients who
have initiated treatment with a single dose of a transmucosal
buprenorphine product or who are already being treated with
buprenorphine. With the tentative approval, Brixadi™ met all
regulatory standards for US approval, including safety, efficacy
and quality, but final market approval of a monthly depot was
determined subject to the expiration of an exclusivity period
granted to Sublocade™ until 30 November
2020.
The 9th of April 2019, Braeburn
filed proceedings in federal court seeking to overturn FDA's
three-year clinical exclusivity decision that is currently blocking
final market approval of Brixadi™. A court hearing was held on
15 July 2019, after which Braeburn's
motion for summary judgment was granted and the case was remanded
to the FDA to reconsider, with deliberate speed, Braeburn's
application for final approval of Brixadi™ Monthly.
In November 2018, Camurus' product
Buvidal® was approved as the first long-acting injection for the
treatment of opioid dependence in the EU and Australia. To date, Buvidal® has been launched
in five EU countries, including Germany and the UK.
About Buvidal® / Brixadi™
Buvidal® (buprenorphine prolonged-release solution for
subcutaneous injection in prefilled syringe) is indicated for the
treatment of opioid dependence within a framework of medical,
social and psychological treatment. Treatment is intended for use
in adults and adolescents aged 16 years or over. Buvidal® is
designed for flexible dosing and is available in four weekly
strengths (8mg, 16mg, 24mg and 32mg) and three monthly strengths
(64mg, 96mg and 128mg), enabling treatment to be tailored to the
patient's individual needs. Administration of Buvidal® is
restricted to healthcare professionals.
Formulated with Camurus' FluidCrystal® injection depot
technology, Buvidal® is presented ready for use in pre-filled
syringes for weekly or monthly administration as small dose volume
subcutaneous injection through a thin, 23-gauge needle. Buvidal®
has been developed for room temperature storage, avoiding the need
for cold chain distribution and refrigerator storage. Therefore, no
mixing steps or room temperature conditioning are required prior to
administration.
Buvidal® has been successfully evaluated in a comprehensive
clinical program comprising five Phase 1 and 2 clinical studies and
two Phase 3 efficacy and long-term safety studies including both
new-to-treatment patients as well as patients switched from
sublingual buprenorphine products. In the pivotal Phase 3 study,
Buvidal® was shown to be at least as effective as standard
treatment with daily buprenorphine/naloxone for the primary
endpoint of the mean percent urine tests negative for illicit
opioids (p<0.001). Superior treatment effect was demonstrated
for the key secondary endpoint of cumulative distribution function
for the percent urine tests negative for illicit opioid use
(p=0.008). The safety profile of Buvidal® was comparable to daily
sublingual buprenorphine, except for mild to moderate injection
site reactions.1
Buvidal® is approved for the treatment of opioid dependence
in Europe and
Australia.
Brixadi™ (the US trade name for Buvidal®) is tentatively
approved by the FDA for patients with opioid use disorder who have
initiated treatment with a single dose of a transmucosal
buprenorphine product or who are already being treated with
buprenorphine.
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.
References
- Lofwall MR, Walsh SL, Nunes
EV, et al. Weekly and monthly subcutaneous buprenorphine depot
formulations vs daily sublingual buprenorphine with naloxone for
treatment of opioid use disorder: A randomized clinical trial. JAMA
Inter Med. 2018;178(6)764–773.
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 2:00 pm CET
on 23 July 2019.
For more information
Fredrik
Tiberg, President & CEO, Head of R&D
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
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