19:39 , Jun 23, 2017 |  BC Week In Review  |  Clinical News

Egalet receives CRL for 10 and 15 mg doses of pain drug Oxaydo

Egalet Corp. (NASDAQ:EGLT) said it received a complete response letter from FDA regarding a prior approval supplement for 10 and 15 mg dose strengths of oral Oxaydo oxycodone (Aversion). FDA requested more information about the...
22:29 , Dec 7, 2016 |  BC Week In Review  |  Clinical News

Oxaydo regulatory update

Egalet said it submitted an sNDA to FDA for oral Oxaydo oxycodone to support an abuse-deterrent label claim for the IV route of abuse. Oxaydo is approved to manage acute and chronic moderate to severe...
02:49 , Nov 10, 2015 |  BC Extra  |  Company News

Tentative FDA approval for Collegium's Xtampza

FDA granted tentative approval for Xtampza ER oxycodone from Collegium Pharmaceutical Inc. (NASDAQ:COLL). The drug is indicated for the management of pain severe enough to require daily around-the-clock opioid treatment and for which alternative treatment...
07:00 , Sep 28, 2015 |  BC Week In Review  |  Company News

Acura, Egalet sales and marketing update

Egalet launched Oxaydo oxycodone in the U.S. for managing acute and chronic moderate to severe pain. Oxaydo, an immediate-release oxycodone tablet without niacin utilizing Acura’s Aversion abuse-deterrent technology, is formulated to deter abuse....
07:00 , Sep 21, 2015 |  BC Week In Review  |  Clinical News

Avridi immediate-release oxycodone regulatory update

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 23-1 against approval of Avridi abuse-deterrent immediate-release oxycodone from Purdue to treat moderate to severe pain where the use of...
07:00 , Sep 21, 2015 |  BC Week In Review  |  Clinical News

Avridi immediate-release oxycodone regulatory update

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 23-1 against approval of Avridi abuse-deterrent immediate-release oxycodone from Purdue to treat moderate to severe pain where the use of...
00:57 , Sep 12, 2015 |  BC Extra  |  Company News

FDA panels back Collegium, spurn Purdue

FDA's Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees voted 23-1 against approval of Avridi immediate-release oxycodone from Purdue Pharma L.P. (Stamford, Conn.). Separately, the committees voted 23-0 to support...
07:00 , Sep 7, 2015 |  BC Week In Review  |  Clinical News

Oxycodone hydrochloride regulatory update

FDA’s Anesthetic and Analgesic Drug Products and Drug Safety and Risk Management advisory committees will hold a joint meeting on Sept. 10 to discuss an NDA for an abuse-deterrent formulation of oxycodone immediate-release tablets from...
07:00 , Aug 17, 2015 |  BC Week In Review  |  Clinical News

Oxycodone: Clinical trial data

Top-line data from a 5-way, crossover, double-blind, active- and placebo-controlled, Category 3 human abuse liability study in 47 non-dependent, recreational opioid users showed that after maximal manipulation drug liking was similar for oral Egalet-002, ...
02:36 , May 13, 2015 |  BC Extra  |  Clinical News

Pain gains on Remoxy, pipeline updates

Pain Therapeutics Inc. (NASDAQ:PTIE) jumped $0.68 (35%) to $2.62 on Tuesday after the company gave a corporate update and said it would resubmit an NDA in 1Q16 for Remoxy, its high viscosity capsule formation of...