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Details:
Under the partnership, Quotient Sciences will support the GMP manufacture and first clinical pharmacokinetic (PK) study for EMPLI03 (buprenorphine) using its unique Translational Pharmaceutics® platform for the treatment of moderate to severe pain.
Lead Product(s): Buprenorphine
Therapeutic Area: Neurology Product Name: Empli03
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Emplicure
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership November 29, 2022
Details:
Belbuca-Generic (buprenorphine) is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. It is indicated to manage chronic pain severe. It has received CRL from FDA for its resubmitted ANDA.
Lead Product(s): Buprenorphine
Therapeutic Area: Neurology Product Name: Belbuca-Generic
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: IntelGenx
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2024
Details:
Buprenorphine Transdermal System is a partial opioid agonist product indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Buprenorphine-Generic
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2023
Details:
Under the agreement with Alar, Indivior will secure exclusive global rights (except in China, Hong Kong, Taiwan and Macau) to develop, manufacture and commercialize ALA-1000 and Alar's future buprenorphine-based LAI product candidates.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: ALA-1000
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alar Pharmaceuticals
Deal Size: $15.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement October 11, 2023
Details:
Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. It is indicated to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid.
Lead Product(s): Buprenorphine
Therapeutic Area: Neurology Product Name: Belbuca-Generic
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 19, 2023
Details:
Under the partnership, Altruix has been selected as a limited distribution partner for Brixadi (buprenorphine), an opioid medication and an extended-release subcutaneous injection indicated for the treatment of moderate to severe opioid use disorder patients.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Brixadi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Altruix
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 17, 2023
Details:
Brixadi™ (buprenorphine) injection for SC, will be indicated for the treatment of 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.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Brixadi
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2023
Details:
Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. It is indicated to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid.
Lead Product(s): Buprenorphine
Therapeutic Area: Neurology Product Name: Belbuca-Generic
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Xiromed
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2023
Details:
BRIXADI is an investigational, extended-release SC injectable therapy 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.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Brixadi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 08, 2022
Details:
BRIXADI, SC injection, will be indicated 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.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Brixadi
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 02, 2022
Details:
Buprenorphine Buccal Film is a generic version of Belbuca®, an opioid that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate.
Lead Product(s): Buprenorphine
Therapeutic Area: Neurology Product Name: Buprenorphine-Generic
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Xiromed
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2022
Details:
EMPLI03, intended for the treatment of moderate to severe pain. 12 healthy subjects were given a single dose of an oral buccal tablet and blood samples were collected for analysis of Buprenorphine.
Lead Product(s): Buprenorphine
Therapeutic Area: Neurology Product Name: EMPLI03
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Quotient Sciences
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 27, 2022
Details:
SUBLOCADE (buprenorphine) injection, for subcutaneous use, indicated for treatment of moderate to severe opioid use disorder in patients who have initiated treatment with transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Sublocade
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 25, 2022
Details:
SUBLOCADE is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Sublocade
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2022
Details:
The modeling data indicate that buprenorphine plasma concentrations of 2 ng/mL and higher may have a protective effect against fentanyl-induced respiratory depression in chronic opioid users, with a reduced probability of apnea following exposure to high fentanyl doses.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Sublocade
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 08, 2022
Details:
Diversifies and expands Collegium’s revenues by adding BELBUCA® as a second and highly complementary growth driver to Collegium’s highly differentiated pain portfolio, in addition to a contributor with SYMPROIC®, and a new product launch opportunity with ELYXYB.
Lead Product(s): Buprenorphine
Therapeutic Area: Neurology Product Name: Belbuca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Collegium Pharmaceutical
Deal Size: $604.0 million Upfront Cash: $604.0 million
Deal Type: Acquisition March 22, 2022
Details:
Diversifies and expands Collegium’s revenues by adding BELBUCA as a second and highly complementary growth driver to Collegium’s highly differentiated pain portfolio, in addition to a contributor with Symproic, and a new product launch opportunity with ELYXYB.
Lead Product(s): Buprenorphine
Therapeutic Area: Neurology Product Name: Belbuca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Collegium Pharmaceutical
Deal Size: $604.0 million Upfront Cash: $604.0 million
Deal Type: Acquisition February 14, 2022
Details:
BELBUCA® (buprenorphine) is a medication administered to help manage chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Lead Product(s): Buprenorphine
Therapeutic Area: Neurology Product Name: Belbuca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alvogen
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 20, 2021
Details:
Buprenorphine is a partial opioid agonist used for management of severe pain that is not responsive to alternative treatments. Also used for maintenance treatment of opioid addiction.SUBLOCADE® for the treatment of moderate to severe opioid use disorder.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Sublocade
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2021
Details:
Data demonstrate LYN-013 delivered sustained buprenorphine drug levels over one-week dosing period and showed sustained suppression of opioid self-administration in an animal model.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: LYN-013
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 25, 2021
Details:
BRIXADI is an investigational, extended-release injection for subcutaneous use that is under review by FDA for the treatment of moderate to severe opioid use disorder, and expects to receive a PDUFA date in 30 days.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Buvidal
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2021
Details:
The approval includes new higher Buvidal monthly 160 mg dose direct initiation onto Buvidal weekly, changing the contraindications in pregnancy and lactation to precautions.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Buvidal
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 03, 2021
Details:
The Buprenorphine release from the ALA-1000 single injection lasts over 12 weeks with effective concentrations, showing low initial burst without dose dumping effect and good safety and tolerability, including local skin irritation and injection pain severity.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: ALA-1000
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2021
Details:
Data from a placebo-controlled study compared safety outcomes of BELBUCA® versus oral oxycodone. BELBUCA® is a buprenorphine buccal film is indicated for the management of severe pain.
Lead Product(s): Buprenorphine
Therapeutic Area: Neurology Product Name: Belbuca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 15, 2021
Details:
Under the terms of the agreement, Accord will commercialize Sixmo®▼ (buprenorphine implant), an opioid agonist therapy treatment, delivered through a first-of-its-kind implant, placed under the skin for six-months.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Sixmo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Molteni Farmaceutici
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement September 14, 2020
Details:
The partnership will establish multichannel digital marketing programs throughout the United States and expand the capabilities for the engagement of health care providers ("HCPs") who are eligible to prescribe Titan's Probuphine® (buprenorphine) implant.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Probuphine
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Indegene Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 24, 2020
Details:
The pivotal Phase 3 efficacy and safety trial demonstrated that Brixadi met the primary endpoint of non-inferiority for responder rate vs current standard of care and superiority for the secondary endpoint for the percentage of negative opioid assessments.
Lead Product(s): Buprenorphine
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2020
Details:
BELBUCA effect on respiratory drive was comparable to placebo at all doses tested.The effect of immediate release oral oxycodone HCl resulted in a dose-dependent decrease in respiratory drive.
Lead Product(s): Buprenorphine
Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 27, 2020
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