Fri, Sep. 11, 6:03 PM
- Collegium Pharmaceutical's (NASDAQ:COLL) Xtampza opioid painkiller moves closer to approval after a panel of outside advisers to the FDA vote unanimously in favor of the drug.
- The advisory panel's vote departed from a recommendation by FDA staff, which had said if the drug was taken without food, it could lead to insufficient pain control, which in turn could contribute to overdosing and misuse.
- Today's vote could provide a boost for other companies developing abuse-deterrent version of painkillers, such as Pernix Therapeutics (NASDAQ:PTX), Egalet (NASDAQ:EGLT), KemPharm (NASDAQ:KMPH), IntelliPharmaCeutics (NASDAQ:IPCI), Pain Therapeutics (NASDAQ:PTIE) and Acura Pharma (NASDAQ:ACUR).
Thu, Jul. 23, 10:43 AM
Thu, Jul. 23, 8:17 AM
Thu, May 21, 10:58 AM
- Thinly traded nano cap Intellipharmaceutics (IPCI +17.3%) heads north on a 10x surge in volume in response to its announcement that the FDA may not require a Phase 3 study for its abuse-deterrent opioid candidate, Rexista Oxycodone XR, if bioequivalence to Purdue Pharma's Oxycontin is demonstrated. The company believes that its previously completed Phase 1 trials fulfill this criterion.
- The firm intends to file its New Drug Application (NDA) within the next 6 - 12 months. Approval is not guaranteed, however. After reviewing the data, the FDA may still require further studies.
- Rexista Oxycodone XR's formulation deters abuse by instantaneously coagulating and entrapping the drug in a viscous hydrogel when pulverized and hydrated. It is also designed to prevent dose dumping if taken with alcohol.
- Related tickers: (PTIE -1.9%)(DRRX)(COLL +1.9%)(ZGNX)(MNK -0.3%)(ACT +1.1%)(TEVA +1.6%)(ABBV -0.7%)(LCI -0.7%)(ALKS -1%)(EGLT -0.1%)(PFE -0.2%)(ACUR -2.4%)
Tue, May 12, 9:16 AM
Tue, May 12, 8:35 AM
- An FDA Category 3 Human Abuse Potential Study with Pain Therapeutics' (NASDAQ:PTIE) Remoxy (oxycodone) Extended-Release Capsules CII showed that both intact and chewed Remoxy was less "liked" than immediate-release oxycodone as measured by the two primary endpoints of Drug Liking and Drug High. The Abuse Potential study was conducted in non-dependent recreational opioid users, per FDA guidelines.
- Remoxy is an oral, long-acting oxycodone gelatin capsule that is being developed by PTIE under a 2002 agreement with Durect (NASDAQ:DRRX). It is formulated with the Durect's ORADUR technology, which uses a high viscosity base component to provide controlled release of the active ingredient over 12 - 24 hours.
- PTIE will host a conference call today at 4:30 pm ET to discuss its progress with its drug candidates and to field questions.
- PTIE shares are up 31% premarket on light volume.
Thu, May 7, 8:45 AM
Tue, Feb. 17, 9:26 AM
- Pain Therapeutics (PTIE +1.5%) Q4 results: Revenues: $0; R&D Expense: $1.1M (-4.3%); SG&A: $1.1M (-10.9%); Net Loss: ($2.2M) (-106.7%); Loss Per Share: ($0.05) (-106.9%).
- FY2014 results: Revenues: $0; R&D Expense: $7.3M (+49.0%); SG&A: $5.1M (+6.3%); Net Loss: ($12.4M) (-139.4%); Loss Per Share: ($0.27) (-138.6%); Quick Assets: $40.6M (-18.5%).
- No guidance given.
Tue, Feb. 17, 8:10 AM
Nov. 3, 2014, 2:14 PM
Oct. 30, 2014, 4:50 PM
Oct. 27, 2014, 12:49 PM
Oct. 27, 2014, 9:26 AM
- Durect Corp. (NASDAQ:DRRX) and Pain Therapeutics (NASDAQ:PTIE) drop 46% and 54%, respectively, on robust volume after Pfizer (NYSE:PFE) decides to discontinue its agreement to development and commercialize Romoxy (oxycodone).
- Pfizer will return all rights, including the responsibility for regulatory activities to Pain, who licensed the product from Durect.
Oct. 27, 2014, 9:13 AM| Oct. 27, 2014, 9:13 AM | 1 Comment
Oct. 23, 2014, 7:15 PM
Aug. 5, 2014, 9:55 AM
PTIE vs. ETF Alternatives
Pain Therapeutics Inc is a biopharmaceutical company that develops novel drugs. The Company has four drug candidates in clinical programs, including Remoxy, Oxytrex, PTI-202 and a novel radio-labeled monoclonal antibody to treat metastatic melanoma.
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