Camurus Announces European Medicines Agency Validation of CAM2038 Marketing Authorization Application for Treatment of Opioid Dependence

PR70367

LUND, Sweden, September 29, 2017 /PRNewswire=KYODO JBN/ --

Camurus (NASDAQ STO: CAMX) today announced the company's Marketing

Authorization Application (MAA) for the investigational, weekly and monthly

CAM2038 buprenorphine depots for the treatment of opioid dependence has been

fully validated by the European Medicines Agency (EMA). The application,

submitted on 26 July 2017, is now under assessment by the Committee for Human

Medicinal Products (CHMP).

"The validation of the MAA for CAM2038 represents a significant step towards

bringing the first long-acting treatment for opioid dependence to patients and

physicians in Europe," said Fredrik Tiberg, President and CEO at Camurus. "If

approved, our weekly and monthly subcutaneous buprenorphine depots could

transform the treatment of opioid dependence by improving treatment outcomes

and reducing the burdens and risks of daily medication."

The MAA is supported by a comprehensive clinical program comprising 7 clinical

studies, including two Phase 3 studies. A core component of the MAA submission

is the positive results from a randomized, double-blind, double-dummy study of

weekly and monthly CAM2038 depot injections versus daily treatment with

sublingual buprenorphine/naloxone in 428 adult patients with opioid use

disorder. The study met the primary endpoint of non-inferiority for mean

percentage urine samples negative for illicit opioids. Superiority was

demonstrated for the first secondary endpoint of cumulative distribution

function for the percentage of urine samples negative for illicit opioids

during treatment weeks 4 to 24. The safety profile of CAM2038 was generally

consistent with the known safety profile of buprenorphine with the exception

for mild-to-moderate injection-site adverse events.

CAM2038 for the treatment of opioid dependence will be reviewed under the

centralized procedure for all 28 EU member states, Norway, Lichtenstein and

Iceland.

For more information about CAM2038, please see the full press release at

http://www.camurus.com.

Camurus AB

Ideon Science Park

SE-223 70 Lund, Sweden

http://www.camurus.com

Phone: +46-46-286-57-30

SOURCE: Camrus AB