Sirgo led the company through the clinical development, US Food and Drug Administration approvals and launches of Onsolis
(fentanyl buccal soluble film), Bunavail (buprenorphine and naloxone) buccal film and Belbuca (buprenorphine) buccal film, while simultaneously transforming BDSI into a fully-integrated pharmaceutical company.
M2 EQUITYBITES-May 13, 2016-BioDelivery Sciences International grants Collegium exclusive US rights to develop and commercialise ONSOLIS
The agreement includes transfering of marketing authorizations for Onsolis
(meant for the treatment of breakthrough pain in patients with cancer who are receiving and are tolerant to opioid therapy for their underlying persistent cancer pain; initially launched in 2009) to BioDelivery to market the drug in the U.S.
For the treatment of pain relief, there is Subutex from Reckitt Benckiser, Onsolis
from Valeant Pharma, and Actig/Fentora from Cephalon.
Only two prescription thin film formulations are FDA approved: Onsolis
(fentanyl, 2009), Suboxone (buprenophine + naloxone, 2010).
One common program also ends the disparity in prescribing requirements for ONSOLIS
(fentanyl buccal soluble film), which is commercialized in the U.S.
The TIRF REMS covers Abstral (fentanyl) sublingual tablet, Actiq (fentanyl citrate) oral transmucosal lozenge and its generic equivalents, Fentora (fentanyl citrate) buccal tablet, Lazanda (fentanyl) nasal spray, and Onsolis
(fentanyl) buccal soluble film.
(142) In July 2009, the FDA approved Onsolis
, a short-acting opioid, to manage pain in cancer patients.
Breakyl, also known as Onsolis
or BEMA Fentanyl, is used for the management of breakthrough pain in opioid tolerant adult patients suffering from cancer.
capsules (extended release) Morphine Sulfate Methadone Hydrochloride, oral Methadone solution * Hydrochloride Methadose, tablets * Methadone Hydrochloride Morphine Sulfate, tablets (immediate Morphine Sulfate release) * Morphine Sulfate, oral solution * Morphine Sulfate MS Contin, tablets (extended Morphine Sulfate release) * Onsolis
, soluble film (buccal) Fentanyl Citrae Opana, tablets (immediate release) Oxymorphone Hydrochloride Opana ER, tablets (extended Oxymorphone release) Hydrochloride Oramorph SR, tablets (sustained Morphine Sulfate release) Oxycontin, tablets (extended Oxycodone release) * Hydrochloride Percocet, tablets * Acetaminophen; Oxycodone Hydrochloride Percodan, tablets * Aspirin; Oxycodone Hydrochloride Xyrem, oral solution Sodium Oxybate
The medication, called Onsolis
, is made by Aveva Drug Delivery Systems and marketed by Meda AB under a license from BioDelivery Sciences International Inc.
M2 PHARMA-May 13, 2016-BioDelivery Sciences International grants Collegium exclusive US rights to develop and commercialise ONSOLIS