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BDSI announces FDA approval of sNDA for new formulation of ONSOLIS (fentanyl buccal soluble film) CII

BioDelivery Sciences International, Inc. announced the approval by the U.S. Food and Drug Administration of a Supplemental New Drug Application (sNDA) for a new formulation of ONSOLIS (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant.

13 Aug 2015

BioDelivery Sciences updates on Clonidine Topical Gel Phase 3 trial for PDN treatment

BioDelivery Sciences International, Inc. announced today that it has completed a pre-specified interim analysis of the ongoing initial pivotal Phase 3 trial for Clonidine Topical Gel for the treatment of painful diabetic neuropathy (PDN).

6 Aug 2014

BioDelivery Sciences receives approval of NDA for BUNAVAIL from FDA

BioDelivery Sciences International, Inc. received approval of the New Drug Application (NDA) for BUNAVAIL™ (buprenorphine and naloxone) buccal film (CIII) from the U.S. Food and Drug Administration (FDA).

9 Jun 2014

Meda reaches agreement with Valeant to terminate joint ventures

Meda has reached an agreement with Valeant to terminate the companies' joint ventures in Canada, Mexico and Australia in the second quarter of 2014. In all three countries own Meda affiliates have been established.

7 Apr 2014

BDSI enrolls first patient in Clonidine Topical Gel Phase 3 trial for treatment of painful diabetic neuropathy

BioDelivery Sciences International, Inc. announced today the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of Clonidine Topical Gel for the treatment of painful diabetic neuropathy.

3 Apr 2014

Biodelivery Sciences collaborates with Quintiles to launch BUNAVAIL in the U.S.

BioDelivery Sciences International, Inc. announced that it has entered into an agreement with Quintiles to provide a range of services to support the anticipated launch of BUNAVAIL (buprenorphine and naloxone buccal film), BDSI's proposed maintenance treatment for opioid dependence.

27 Mar 2014

BioDelivery Sciences International submits BUNAVAIL NDA to FDA

BioDelivery Sciences International, Inc. announced today that it engaged in a positive pre-New Drug Application meeting with the U.S. Food and Drug Administration regarding BUNAVAIL for the maintenance treatment of opioid dependence.

10 Jun 2013

Enrollment complete in BDSI's pivotal pharmacokinetic study of BNX for opioid dependence

BioDelivery Sciences International, Inc. announced that enrollment and the clinical portion of the pivotal pharmacokinetic study for BEMA Buprenorphine/Naloxone (BNX) for the treatment of opioid dependence has been completed.

20 Aug 2012

BDSI announces postponement of ONSOLIS U.S. relaunch

BioDelivery Sciences International, Inc. today announced that the U.S. relaunch of ONSOLIS (fentanyl buccal soluble film) is being postponed until the product formulation can be modified to address two appearance issues raised by the U.S. Food and Drug Administration (FDA) following a recent inspection of the Aveva manufacturing facility where ONSOLIS is produced.

12 Mar 2012

USPTO rejects MonoSol's patent infringement claims against BDSI

The United States Patent & Trademark Office has informed BioDelivery Sciences International, Inc. that it has rejected all claims by MonoSol Rx, LLC (MonoSol) in its US Patent No. 7,425,292 (the '292 Patent) which is currently being asserted against BDSI and its commercial partners for ONSOLIS.

23 Feb 2012

Endo, BDSI partner to develop and commercialize BEMA Buprenorphine for chronic pain

BioDelivery Sciences International, Inc. today announced the signing of a worldwide license and development agreement with Endo Pharmaceuticals for the exclusive rights to develop and commercialize BEMA Buprenorphine for the treatment of chronic pain.

6 Jan 2012

Single shared REMS for TIRF products receives FDA approval

The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products. This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system.

30 Dec 2011

Positive results from BDSI's BEMA Buprenorphine/Naloxone formulation Phase 1 study on opioid dependence

BioDelivery Sciences International, Inc. announced positive preliminary results from its Phase 1 study assessing the pharmacokinetics of a BEMA Buprenorphine/Naloxone formulation.

6 Sep 2011

BDSI completes BEMA Buprenorphine Phase 3 trial on chronic pain

BioDelivery Sciences International, Inc. announced today that the last patient has completed the randomized portion of its Phase 3 clinical trial assessing the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain, signifying completion of the trial.

25 Jul 2011

BDSI's BEMA drug delivery technology receives Canada patent

BioDelivery Sciences International, Inc. announced the issuance of a patent extending the exclusivity of the BioErodible MucoAdhesive drug delivery technology in Canada from 2017 to 2027. The patent was been reviewed by the Office of Patented Medicines for listing in the Canadian Patent Register and was found eligible for listing.

22 Mar 2011

BDSI prices $15 million private placement

BioDelivery Sciences International, Inc. announces that it has received definitive commitments from institutional investors for a private placement financing yielding gross proceeds of $15 million to BDSI. The financing is expected to close today.

11 Mar 2011

BDSI announces over 50% enrolled in BEMA Buprenorphine Phase 3 study in chronic pain

BioDelivery Sciences International, Inc. announced today that enrollment of its Phase 3 trial assessing the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain is on schedule, with over half of the needed subjects enrolled.

18 Feb 2011

BDSI refutes MonoSol's patent infringement claims relating to BEMA Buprenorphine

BioDelivery Sciences International, Inc. today responded to a process patent infringement lawsuit filed and recently served against the Company and certain co-defendants by MonoSol Rx, LLC. The purpose in responding at this time is for BDSI to strongly refute MonoSol's claims and to assure BDSI stockholders that the Company remains focused on vigorously progressing its pipeline and not allowing this claim to present a distraction.

24 Jan 2011

BDSI initiates dosing in BEMA Buprenorphine Phase 3 clinical program for chronic pain

BioDelivery Sciences International, Inc. today announced the enrollment and dosing of the first patient in its Phase 3 clinical program evaluating the efficacy and safety of BEMA Buprenorphine for the treatment of moderate to severe chronic pain.

9 Dec 2010

BDSI to initiate BEMA Buprenorphine Phase 3 program following positive End-of-Phase 2 meeting with FDA

BioDelivery Sciences International, Inc. today announced a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) which took place on September 14, 2010. At that meeting, agreement was reached on the BEMA Buprenorphine development plan for the treatment of chronic pain.

28 Oct 2010