Key Developments: DURECT Corp (DRRX.OQ)
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2 Aug 2013
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Latest Key Developments (Source: Significant Developments)
DURECT Corp Announces FDA Acceptance Of New Drug Application (NDA) Submission For Posidur
DURECT Corp announced that the New Drug Application (NDA) for the investigational product POSIDUR (SABER-Bupivacaine) has been accepted by the U.S. Food and Drug Administration (FDA) indicating that the application is sufficiently complete to permit a substantive review. POSIDUR is a post-operative pain relief depot that utilizes DURECT's patented SABER technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery. DURECT submitted the NDA as a 505(b)(2) application. The Prescription Drug User Fee Act (PDUFA) goal date (the date the FDA expects to complete its review of the NDA) has been confirmed as February 12, 2014. Full Article
DURECT Corp Announces Submission Of New Drug Application For POSIDUR (SABER-Bupivacaine)
DURECT Corp announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational product POSIDUR (SABER-Bupivacaine). POSIDUR is a post-operative pain relief depot that utilizes DURECT's patented SABER technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery. DURECT submitted the NDA as a 505(b)(2) application. Full Article
DURECT Corp Licensee Zogenix Inc Announces Positive Results from Relday Phase 1 Clinical Trial
DURECT Corp announced that its licensee, Zogenix Inc, reported positive single-dose pharmacokinetic (PK) results from the Phase 1 clinical trial of Relday, an investigational candidate of a , once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia. According to Zogenix, adverse events in the Phase 1 trial in patients diagnosed with schizophrenia were generally mild to moderate and consistent with other risperidone products. The Phase 1 clinical trial for Relday was conducted as a single-center, open-label, safety and PK trial of 30 patients with chronic, stable schizophrenia or schizoaffective disorder. Per Zogenix, based on the favorable safety and PK profile demonstrated with the 25 mg and 50 mg once-monthly doses tested in the Phase 1 trial, Zogenix has extended the study to include a 100 mg dose of the same formulation. The addition of this dose arm to the study will enable evaluation of dose proportionality across the full dose range that would be anticipated to be used in clinical practice. Zogenix expects to complete the extension of the Phase 1 clinical trial during the second quarter of 2013. Full Article
DURECT Corp Announces Pricing of Public Offering of Common Stock
DURECT Corp announced the pricing of an underwritten public offering of 14 million shares of its common stock, offered at a price of $0.90 per share to the public. The gross proceeds to DURECT from this offering are expected to be approximately $12.6 million, before deducting underwriting discounts and commissions, and other estimated offering expenses payable by DURECT. All of the shares in the offering are to be sold by DURECT. The offering is expected to close on or about December 11, 2012. Full Article
DURECT Corporation Announces Intent To Submit NDA For POSIDUR For Post-Operative Analgesia
DURECT Corporation announced that it has completed its pre-NDA communications with the United States Food and Drug Administration (FDA) regarding POSIDUR (SABER-Bupivacaine). Through this process, DURECT has received guidance and thoughtful comments from the FDA covering various chemistry, manufacturing, non-clinical, clinical pharmacology, clinical, statistical and product labeling topics based on our pre-NDA meeting questions. We have sent to the FDA meeting minutes and are awaiting their final concurrence on those minutes. With the input we have received from the FDA, DURECT intends to prepare and submit a new drug application (NDA) under 505(b) with the FDA in late 2012 or early 2013. POSIDUR is our investigational post-operative pain relief depot that utilizes our patented SABER technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery. Full Article
DURECT Corporation Announces Issuance Of U.S. Patents Covering ORADUR Technology
DURECT Corporation announced the issuance of four patents by the United States Patent and Trademark Office (USPTO) covering DURECT's ORADUR technology. These patents provide additional intellectual property protection for REMOXY (oxycodone) Extended-Release Capsules CII and other ORADUR-based opioids until at least 2025. REMOXY, based on DURECT's ORADUR technology, is an investigational drug that is a unique, controlled release formulation of oxycodone for moderate-to-severe chronic pain designed to reduce potential risks of unintended use. The four recently issued patents are U.S. Patent Nos. 8,133,507; 8,147,870; 8,153,152; and 8,168,217. The '507, '152, and '217 patents claim oral formulations comprising an opioid, such as oxycodone, and other components. The '870 patent claims methods of making opioid-containing formulations. Full Article
DURECT Corporation Announces Top-Line Data From BESST (POSIDUR U.S. Pivotal Phase III Trial)
DURECT Corporation announced top-line results from the U.S. pivotal Phase III clinical study for POSIDUR known as BESST (Bupivacaine Effectiveness and Safety in SABER trial). POSIDUR is a post-operative pain relief depot that utilizes DURECT's patented SABER technology to deliver bupivacaine and is designed to provide up to three days of pain relief after surgery. BESST was conducted to measure the safety and efficacy of POSIDUR versus placebo in one abdominal surgical procedure and versus an active comparator (injections of standard bupivacaine) in two other abdominal surgical procedures. The co-primary endpoints were pain intensity as well as the use of opioid analgesics over the first 3 days following surgery. While the results trended positive for both pain reduction and reduction of supplemental opioid use in the first three days after surgery, they did not reach statistical significance. There were no signs of systemic safety issues, although local site reactions were observed more frequently in the POSIDUR and SABER-Placebo groups than in the active comparator groups. A full safety assessment is not yet available. Full Article
Pain Therapeutics, Durect shares soar on Pfizer's Remoxy comments
- Shares of Pain Therapeutics Inc and Durect Corp rose more than 40 percent after partner Pfizer Inc said it is in talks with U.S. health regulators to find a way forward on the companies' painkiller, Remoxy.

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