Profile: DURECT Corp (DRRX.OQ)
1.27USD
2 Aug 2013
$0.02 (+1.60%)
$1.25
$1.25
$1.27
$1.23
10,150
121,323
$1.85
$0.61
Durect Corporation, incorporated on February 6, 1998, is a specialty pharmaceutical company focused on the development of pharmaceutical products based on its drug delivery technology platforms. The Company’s product pipeline, as of December 31, 2012, consisted of eight investigational drug candidates in clinical development, with one program the subject of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA), with one program in Phase III with an NDA in preparation, two programs in Phase II and three programs in Phase I. The Company’s products candidates include Remoxy, POSIDUR, ELADUR, TRANSDUR-Sufentanil, Relday, ORADUR-based opioid, ORADUR-ADHD, Relday and other products. The Company's developments are focused on the application of its drug delivery technologies to potential products in a variety of chronic and episodic disease areas, including pain, central nervous system (CNS) disorders, cardiovascular disease and other chronic diseases.
REMOXY (ORADUR-Oxycodone)
REMOXY is an oral oxycodone gelatin capsule under development with Pain Therapeutics, Inc. (Pain Therapeutics) to which it has licensed exclusive, worldwide, development and commercialization rights under a development and license agreement. REMOXY is formulated with its ORADUR technology and incorporates several abuse-deterrent properties with the convenience of twice-a-day dosing. Oxycodone is also the active drug ingredient in OxyContin.
POSIDUR (SABER-Bupivacaine)
The Company is developing POSIDUR, a sustained-release formulation of bupivacaine, using its SABER delivery system for the treatment of post-surgical pain. The hernia pivotal efficacy clinical trial was designed to evaluate the tolerability, activity, dose response and pharmacokinetics of POSIDUR in patients undergoing open inguinal hernia repair. The trial was conducted in Australia and New Zealand as a multi-center, randomized, double blind, placebo-controlled study in 122 patients. In the POSIDUR Phase II and III clinical development program, 668 were treated with POSIDUR, 268 with SABER-Placebo (SABER vehicle without drug) and 124 with bupivacaine HCl solution as of December 31, 2012.
ELADUR
The Company is developing a transdermal bupivacaine patch (ELADUR) to provide continuous delivery of bupivacaine for up to three days from a single application, as compared to a wearing time limited to 12 hours with available lidocaine patches. In its study of 263 patients suffering from chronic low back pain, the primary efficacy endpoint of demonstrating a positive treatment difference for the mean change in pain intensity scores from baseline to the mean of weeks 11 and 12 between ELADUR as compared to placebo was not met.
TRANSDUR-Sufentanil Patch
The Company’s transdermal sufentanil patch (TRANSDUR-Sufentanil) under development is based on the TRANSDUR transdermal technology. It is intended to provide continuous delivery of sufentanil for up to seven days from a single application, as compared to the two to three days of relief provided by available fentanyl patches. Sufentanil is a potent opioid, which is used in hospitals as an analgesic for which the patent covering the chemical entity has expired.
ORADUR-ADHD Program
The Company is developing a drug candidate (ORADUR-ADHD) based on DURECT’s ORADUR Technology for the treatment of attention deficit hyperactivity disorder (ADHD). This drug candidate is intended to provide once-a-day dosing with added tamper resistant characteristics to address methods of abuse and misuse of these types of drugs. During the year ended December 31, 2012, it conducted Phase I clinical trials in this program with multiple formulations. Based on information from these trials, it is continuing to evaluate the formulations and is planning next steps in its ORADUR-ADHD program.
Relday
On January 3, 2013, Zogenix, Inc. (Zogenix) reported positive single-dose pharmacokinetic (PK) results from the Phase I clinical trial of Relday. According to Zogenix, adverse events in the Phase I trial in patients diagnosed with schizophrenia were generally mild to moderate and consistent with other risperidone products. The Phase I 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.
The TRANSDUR Transdermal Delivery System
The Company’s TRANSDUR technology is a transdermal delivery system, which enables delivery of drugs continuously for up to seven days. The TRANSDUR technology is the basis for TRANSDUR-Sufentanil, for which it has conducted Phase II clinical trials, and for which it holds worldwide development and commercialization rights. The TRANSDUR technology is also the basis for ELADUR, for which it has conducted two Phase II clinical trials, and for which it holds worldwide development and commercialization rights.
The ORADUR Sustained Release Gel Cap Technology
The Company is developing ORADUR sustained release oral technology based on the SABER technology. Products based on the ORADUR technology can take the form of an easy to swallow gelatin capsule that uses a high-viscosity base component, such as sucrose acetate isobutyrate (SAIB) to provide controlled release of active ingredients for a period of 12 to 24 hours of drug delivery. The ORADUR technology is the basis of Remoxy, an oral formulation of the opioid oxycodone, which is focused to decrease the potential for oxycodone abuse. Phase I clinical trials has been conducted for two of these ORADUR-based products (hydrocodone and hydromorphone), and an IND has been accepted by the FDA for the third ORADUR-based opioid (oxymorphone). It also has an ORADUR-ADHD program, for which it and Orient Pharma have conducted several Phase I clinical trials with multiple formulations during 2012.
The DURIN Biodegradable Implant Technology
The DURIN technology is a biodegradable implant, which enables parenteral delivery of drugs from several weeks to six months or more using the LACTEL brand polymers and co-polymers of lactic and glycolic acid. The DURIN technology can deliver a range of drugs, including small and large molecule compounds. The Company’s implant design allows for a range of possible delivery profiles, including constant rate delivery.
The Company competes with Purdue Pharma, Knoll, Janssen, Medtronic, Endo, AstraZeneca, Arrow International, Tricumed, I-Flow (Kimberly-Clark), Cumberland Pharmaceuticals, NeurogesX, Covidien, Shire, Johnson & Johnson, Eli Lilly, Pfizer, Novartis, Flamel, Alexza, Cadence Pharmaceuticals, Hospira, Cumberland Pharmaceuticals, Egalet and Acura.
Company Address
DURECT Corp
10260 Bubb Road
CUPERTINO CA 95014-4166
P: +1408.7771417
F: +1408.7773577
Company Web Links
| Name | Compensation |
|---|---|
Felix Theeuwes |
480,980 |
James Brown |
598,491 |
Matthew Hogan |
410,914 |
Su Il Yum |
418,905 |
David Hoffmann |
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