DURECT's Endogenous Epigenomic Regulator DUR-928 - What You Need To Know
Jason Napodano, CFA
Jason Napodano, CFA
Tue, Sep. 27, 12:52 PM
Tue, Sep. 27, 11:00 AM
Tue, Sep. 27, 9:16 AM
Mon, Sep. 26, 12:48 PM
Mon, Sep. 26, 12:29 PM
- Thinly traded micro cap Pain Therapeutics (NASDAQ:PTIE) craters 67% premarket on increased volume in response to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) seeking approval of abuse-deterrent REMOXY ER (oxycodone capsules CII).
- The CRL informs the company that additional actions and data are required for approval. Management says the actions will take about a year to complete and could cost $5M.
- Specifically, to support a claim against abuse by injection, it will need to repeat an injectability/syringeability study using thin films of drug, smaller volumes of solvents, additional mixed solvents and alternative extraction methods and syringe filter. To support a claim against abuse by inhalation, it will need to repeat a volatilization study using the same thickness for each drug to increase surface area. To support a claim against abuse by snorting, it will need to conduct an intranasal abuse potential study in human volunteers (the company submitted animal data in its NDA) with drug applied directly inside the human nasal cavity.
- In addition, the agency stated that Pain's clinical data to support a claim against abuse by chewing is not sufficient and it will need to submit a revised proposed label to indicate that the results from the study do not support the claim.
- The filing was the company's third attempt at approval.
- The company will host a conference call this morning at 9:00 am ET to discuss the situation.
- Remoxy licensor DURECT (DRRX -31.8%) is feeling a bit of pain as well.
Mon, Sep. 26, 11:00 AM
Mon, Sep. 26, 9:13 AM
Mon, Aug. 1, 4:10 PM
Tue, Jul. 12, 12:30 PM| Tue, Jul. 12, 12:30 PM | 12 Comments
Fri, Jul. 1, 9:55 AM
- DURECT (DRRX +1.7%) announces that the FDA's Anesthetic and Analgesic Drug Products Advisory Committee will meet on August 5 to discuss the New Drug Application (NDA) filed by licensee Pain Therapeutics (PTIE -0.2%) seeking approval of REMOXY (oxycodone capsules CII) for the treatment of pain severe enough to require daily, around-the-clock. long-term opioid treatment.
- The PDUFA date remains September 25.
- Update: On July 1, DURECT announced that the FDA determined that an Ad Comm review is unneeded and will not be held. The PDUFA date remains as is. Licensee Pain Therapeutics (PTIE +6.8%) is up on the news.
Thu, May 5, 4:49 PM
Tue, Apr. 26, 9:16 AM
Tue, Apr. 26, 7:49 AM
- DURECT Corp. (NASDAQ:DRRX) is down 7% premarket on light volume in response to its announcement that it is preparing an equity offering. Price, volume and terms have yet to be announced. Net proceeds will be used for general corporate purposes.
- Update: The offering is 12M shares of common stock at $1.25 per share. Underwriters over-allotment is an additional 1.8M shares. Closing date is April 29.
Tue, Apr. 12, 6:00 PM
- The FDA accepts for review Pain Therapeutics' (NASDAQ:PTIE) New Drug Application (NDA) seeking approval of lead product candidate REMOXY, an abuse-deterrent formulation of extended-release oxycodone capsules. The agency's action date (PDUFA) is September 25. This is the third attempt at approval.
- REMOXY's abuse-deterrence characteristics are based on Durect's (NASDAQ:DRRX) ORADUR technology which uses a high viscosity base component to provide controlled release of the active ingredient over 12-24 hours. Pain Therapeutics licensed the technology in 2002.
- Management will host a conference call tomorrow morning at 8:30 am ET to discuss the NDA and the market opportunity.
- Shares are up 2% after hours on robust volume.
- Previously: Pain Therapeutics tries again with REMOXY NDA (March 29)
Tue, Mar. 29, 10:37 AM
- Pain Therapeutics (PTIE -1.9%) files its New Drug Application (NDA) with the FDA seeking approval of REMOXY, an abuse-deterrent formulation of extended-release oxycodone capsules, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment.
- The filing is a resubmission. The original NDA was filed by the company in June 2008. It received a CRL six months later. King Pharmaceuticals, who assumed control of development in March 2009, resubmitted the NDA in December 2010. The FDA responded with another CRL to Pfizer (acquired King in February 2011) in June 2011. The issues pertained principally to manufacturing consistency and how it related to the consistency of the drug inside the body. Pfizer eventually gave up and returned the rights to the drug to Pain Therapeutics in October 2014.
- REMOXY's abuse-deterrence characteristics are based on Durect's (DRRX -0.8%) ORADUR technology which uses a high viscosity base component to provide controlled release of the active ingredient over 12-24 hours. Pain Therapeutics licensed the technology in 2002.
- Previously: Pain Therapeutics' oral oxycodone successful in abuse deterrent study; shares rise (May 12, 2015)
Mon, Feb. 29, 4:25 PM
- Durect (NASDAQ:DRRX): Q4 EPS of -$0.05 beats by $0.01.
- Revenue of $5.2M (+21.8% Y/Y) beats by $0.37M.