Le Lézard
Classified in: Health
Subject: FDA

Camurus Announces Positive Outcome of U.S. Court Proceeding About Final Approval of Brixaditm


FDA ordered to reconsider, with deliberate speed, Braeburn's application for final approval of Brixaditm

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 Brixaditm Monthly. The court rules that, in December 2018, the FDA acted inconsistently with precedent by delaying the approval of Brixaditm and granting a three-year exclusivity to Sublocadetm. The case is remanded to the FDA to reconsider, with deliberate speed, Braeburn's application for final approval of Brixaditm 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 Brixaditm 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 Brixaditm 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, Brixaditm 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 Sublocadetm 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 Brixaditm. 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 Brixaditm 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® / Brixaditm

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. 

Brixaditm (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

  1. 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

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/camurus-ab/r/camurus-announces-positive-outcome-of-us-court-proceeding-about-final-approval-of-brixadi-,c2868094

The following files are available for download:

https://mb.cision.com/Main/13456/2868094/1081187.pdf

Press release.pdf

 


These press releases may also interest you

at 02:05
Agilent Technologies Inc. announced today that Professor Hualiang Jiang has received an Agilent Thought Leader Award. Professor Jiang directs the Shanghai Institute of Materia Medica at the Chinese Academy of Sciences and is a leading researcher in...

at 01:05
Novigenix SA, a leading Immuno-Transcriptomics company that develops and commercializes solutions for early cancer detection and precision medicine, today announced a collaboration agreement with BioLizard, an innovative bioinformatics company that...

at 01:05
Takeda Pharmaceutical Company Limited ("Takeda") (TOKYO:4502/NYSE:TAK) today announced that it has been named in the 2019 Dow Jones Sustainability World Index, achieving more than double the average overall industry score. In addition, Takeda was...

at 00:05
Last year, over 23,500 youth (age 10 to 24) were hospitalizedi for harm caused by substance use ? the equivalent of 65 hospitalizations each day. A new report from the Canadian Institute for Health Information (CIHI) shows that cannabis and alcohol...

at 00:01
An article recently published in Radiology highlights the groundbreaking use of a new imaging technology introduced by Seno Medical Instruments, Inc.® (Seno Medical) to diagnose breast cancer. The technology may offer physicians a new, non-invasive...

at 00:00
Attorney Corsello has been practicing personal injury litigation and criminal law for over 35 years. He received his JD degree from Suffolk University Law School and his BA degree from the University of Connecticut. He was admitted to the Connecticut...



News published on 23 july 2019 at 08:11 and distributed by: