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Durect Corporation

Partner : Pfizer, Pain Therapeutics

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DURECT Announces FDA Acceptance of REMOXY® NDA, PDUFA Date of September 25, 2016
CUPERTINO, Calif., April 12, 2016 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced its licensee, Pain Therapeutics (Nasdaq: PTIE), has been informed by the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for REMOXY®, an abuse-deterrent formulation of extended-release oxycodone (CII) capsules, is sufficiently complete to permit a substantive review, and that September 25, 2016 is the target action date under the Prescription Drug User Fee Act (PDUFA).
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Source: press release, 4/12/16. http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID...

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DURECT Announces Resubmission of REMOXY® New Drug Application to the U.S. Food and Drug Administration
CUPERTINO, Calif., March 29, 2016 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced its licensee, Pain Therapeutics (Nasdaq: PTIE), has resubmitted the New Drug Application (NDA) for REMOXY® (oxycodone capsules CII) to the U.S. Food and Drug Administration (FDA). Pain Therapeutics has stated that they expect to be notified by the FDA of a Prescription Drug User Fee Act (PDUFA) action date within 30 days. The original REMOXY NDA has a Priority Review Designation.

"We are pleased to have the REMOXY NDA resubmitted to the FDA as we believe that REMOXY can play a meaningful role in controlling the pain of the large population of legitimate chronic pain patients who have a need for such products while at the same time incorporating abuse-deterrent properties that may play a role in reducing oxycodone misuse that is such a pressing public healthcare issue," said James E. Brown, President and CEO of DURECT.

Chronic pain affects as many as 100 million Americans annually. When chronic pain is severe enough, patients are frequently prescribed long-acting opioid analgesics. Opioids (also called narcotics) include oxycodone, hydrocodone, hydromorphone, oxymorphone, morphine, fentanyl, methadone, and other members of this class. OxyContin®, a brand name oral extended-release oxycodone-based painkiller, accounted for approximately $2.4 billion in sales in the U.S. in 2014. While opioids are effective at treating pain, they are also widely misused and abused. The FDA has recently described this situation as the opioid abuse epidemic, and called for a far-reaching action plan to reassess the agency's approach to opioid medications. One element of this action plan includes expanding access to, and encouraging the development of, abuse-deterrent formulations of opioid products.
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Source: press release, 3/29/16. http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID...

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James E. Brown, D.V.M., President and CEO, gave guidance for the regulatory resubmission for Remoxy by partner Pain Therapeutics. He stated, "I now want to move on to Remoxy. Pain Therapeutics, has been focused on the Remoxy NDA resubmission, and it is our understanding, Pain Therapeutics expects to resubmit the NDA in the first quarter of this year, this quarter. After resubmission, there should be a six months review by the FDA. As such, we look forward to the approval of Remoxy in the fall. Based on those timelines, Remoxy would be eligible for approval in the third quarter, at the end of third quarter or early fourth quarter of this year. So, we potentially are about two quarters away from having our first approved pharmaceutical product."
Source: Q4 2015 earnings conference call, 2/29/16.

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PAIN THERAPEUTICS ANNOUNCES POSITIVE TOP-LINE RESULTS FROM HUMAN ABUSE POTENTIAL STUDY WITH REMOXY

REMOXY Meets Both Primary Endpoints with Statistical Significance (p < 0.0001)

AUSTIN, Texas, May 12, 2015 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc., (Nasdaq:PTIE) today announced top-line results of an FDA Category 3 Human Abuse Potential Study with REMOXY Extended-Release Capsules CII, its lead drug candidate that is specifically designed to discourage certain common methods of drug tampering and misuse. This study demonstrated with statistical significance (p < 0.0001) that both intact and chewed REMOXY were less "liked" than immediate-release oxycodone on the two primary endpoints, Drug Liking and Drug High. The Abuse Potential study was conducted in non-dependent, recreational opioid users, as recommended by FDA guidelines.

"We believe today's results demonstrate abuse-deterrent properties of the REMOXY formulation against a common, and often lethal, form of oral drug abuse," said Nadav Friedmann, PhD, MD., Pain Therapeutics' Chief Medical Officer.

Study Design

Pain Therapeutics' former corporate partner for REMOXY had sole responsibility for this FDA Category 3 Human Abuse Potential Study with REMOXY. This study was conducted in accordance with draft FDA Guidance to Industry on Abuse Deterrent Opioids and interactions between the study sponsor and FDA. The study was randomized, double-blind, placebo and active controlled, using a 4-way crossover design in healthy, non-dependent recreational opioid users. Nearly 60 subjects completed this study, with an average age of 27 years. The study's primary objective was to measure the abuse potential of chewed and intact 40mg REMOXY compared to 40mg immediate-release (IR) oxycodone when taken orally. Study subjects were instructed to chew REMOXY capsules vigorously for up to 5 minutes, but none were able to do so in light of REMOXY's high viscosity, texture or taste. Pharmacodynamic measures of the primary endpoints, Drug Liking and Drug High, included use of a standard 0-100 point Visual Analogue Scale (VAS) in the initial two hours post-dose (AUC02h), as recommended by FDA to assess a formulation's abuse potential. The sponsor generated study tables for this Abuse Potential Study in December 2014. Pain Therapeutics has not performed an independent analysis of study results.

Top-line Study Results

Clinical and statistical highlights include:

On the co-primary endpoint of Drug Liking, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0001) compared to IR oxycodone.
On the co-primary endpoint of Drug High, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0001) compared to IR oxycodone.
On the secondary endpoint of Good Drug Effects, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0001) compared to IR oxycodone.
On the secondary endpoint of Bad Drug Effects, scores were significantly higher for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0079) compared to IR oxycodone.
On the secondary endpoint of Pupil Constriction, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0001) compared to IR oxycodone.

On the secondary endpoint of Nausea, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0143) compared to IR oxycodone.
On the secondary endpoint of Feel Sick, scores were significantly lower for intact REMOXY (p < 0.0002) and for chewed REMOXY (p < 0.039) compared to IR oxycodone.
"We believe results of today's study speak to the clinical and commercial potential of REMOXY," said Remi Barbier, President & CEO of Pain Therapeutics. "REMOXY's high viscosity is intended to deter injection and snorting. We believe this feature, coupled to today's data on oral abuse, contributes to an overall assessment of abuse potential that supports a label-claim for REMOXY."
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Source: press release, 5/12/15. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=912547

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Regulatory Strategy

REMOXY's previous sponsor reached agreement with the FDA on the specific contents of an acceptable NDA resubmission. As with all regulatory documents, this agreement is now assigned to us as part of the REMOXY transition. We believe these regulatory documents create a clear path to the FDA for re-filing the REMOXY NDA.

We plan to refile the REMOXY NDA with FDA in Q1 2016. If accepted by the FDA, we believe the REMOXY NDA will undergo a six-month review cycle.

We have assembled a highly experienced team of experts, consultants and vendors from a range of disciplines to handle the complexities of preparing an electronic NDA submission.
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Source: press release, 5/11/15. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=912448

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REMOXY (oxycodone) Extended-Release Capsules CII. Following guidance received from the FDA in 2013 and having achieved technical milestones related to manufacturing, Pfizer announced in October 2013 that they would proceed with the additional clinical studies and other actions required to address the Complete Response Letter received in June 2011. Pfizer stated that these new clinical studies would include, in part, a pivotal bioequivalence study with the modified REMOXY formulation to bridge to the clinical data related to the original REMOXY formulation, and an abuse-potential study with the modified formulation. According to information posted to ClinicalTrials.gov, we understand these studies have been completed, although we have not been provided any results. Pfizer notified Pain Therapeutics in late October 2014 that Pfizer had decided to discontinue development of REMOXY. Pfizer has stated that they will return all rights, including responsibility for regulatory activities, to Pain Therapeutics. Additionally, Pfizer has stated that they will continue ongoing activities under the agreement with Pain Therapeutics until the scheduled termination date in April 2015. Pain Therapeutics has stated that it is focused on an orderly transfer of the program back from Pfizer, finalizing a strategy around the prospect of resubmitting the NDA, and seeking a new commercialization partner.
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Source: press release, 3/02/15. http://phx.corporate-ir.net/phoenix.zhtml?c=121590&p=irol-newsArticle&ID...

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DURECT Provides Update on REMOXY® and POSIDUR™ Programs

CUPERTINO, Calif., Oct. 27, 2014 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) reported today that Pfizer Inc. (NYSE: PFE) announced today that it has notified Pain Therapeutics, Inc. (Nasdaq: PTIE) that Pfizer has decided to discontinue its agreement to develop and commercialize REMOXY® (oxycodone) Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone. Pfizer will return all rights, including responsibility for regulatory activities, to Pain Therapeutics. As a result, Pain Therapeutics has the rights to develop and commercialize REMOXY on its own or with an alternative licensee. Pain Therapeutics had the rights to develop and commercialize this product candidate under a license from DURECT.

Pfizer further announced that it has concluded an internal review of the top-line results of five recently completed clinical studies required to address the Complete Response Letter received in June 2011 from the U.S. Food and Drug Administration (FDA), that Pfizer and Pain Therapeutics will work together for an orderly transition of REMOXY to Pain Therapeutics, and that Pfizer will continue ongoing activities under the agreement for the next six months until the scheduled termination date.

"We are surprised by Pfizer's decision given the late stage of this program, and continue to believe that REMOXY could play an important role in serving the needs of chronic pain patients while potentially reducing the misuse and abuse of oxycodone," stated James Brown, President and CEO of DURECT. "With respect to POSIDUR, we had a face-to-face meeting with the FDA on September 23 to discuss what needs to be done to address the issues cited in the Complete Response Letter, and we are currently awaiting feedback from the FDA regarding our questions posed at the meeting."
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Source: press release, 10/27/14. http://phx.corporate-ir.net/phoenix.zhtml?c=121590&p=irol-newsArticle&ID...

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Pfizer Proceeding with REMOXY® Development

CUPERTINO, Calif., Oct. 22, 2013 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) announced today that Pfizer Inc. (NYSE: PFE) has stated that, having achieved technical milestones related to manufacturing, they will continue the development program for REMOXY® (oxycodone) Extended-Release Capsules CII. Following guidance received from the U.S. Food and Drug Administration (FDA) earlier this year, Pfizer announced that they will proceed with the additional clinical studies and other actions required to address the Complete Response Letter received in June 2011. These new clinical studies will include, in part, a pivotal bioequivalence study with the modified REMOXY formulation to bridge to the clinical data related to the original REMOXY formulation, and an abuse-potential study with the modified formulation. As previously disclosed, the complete response submission is not expected to occur prior to mid-2015.

"We are pleased that, after a thorough review and having achieved technical milestones, Pfizer is proceeding with development of REMOXY," stated James Brown, President and CEO of DURECT. "We continue to believe that REMOXY could play an important role in serving the needs of chronic pain patients while potentially reducing the misuse and abuse of oxycodone."

In addition, Pain Therapeutics, Inc. (Nasdaq: PTIE) has regained all rights from Pfizer with respect to the three other ORADUR-based opioid drug candidates (hydrocodone, hydromorphone and oxymorphone). Pain Therapeutics is now free to develop and commercialize these product candidates on its own or with a licensee. Investigational New Drug (IND) applications for these drug candidates are in place with the FDA. Pain Therapeutics has stated that they have not yet made a decision to develop or out-license the three product candidates.
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Source: press release, 10/22/13. http://phx.corporate-ir.net/phoenix.zhtml?c=121590&p=irol-newsArticle&ID...

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REMOXY (oxycodone) Extended-Release Capsules CII. Pfizer has efforts underway to resolve the issues raised in the REMOXY Complete Response Letter, which are primarily related to manufacturing. In May 2013, Pfizer stated that they had met with the FDA in March 2013 to discuss their plan to address the Complete Response Letter, and that they had received written guidance from the FDA in May 2013 regarding required next steps, including additional clinical studies, to address the letter. We understand from Pfizer that these additional clinical studies include, in part, a pivotal bioequivalence study with the modified formulation to bridge to the clinical data conducted with the original formulation, as well as an abuse potential study with the modified REMOXY formulation. Based on this guidance from the FDA, Pfizer stated that they are considering their options with respect to REMOXY. Further, if Pfizer elects to continue development of REMOXY, which we expect will be determined in the fall of 2013, Pfizer stated that they would not expect to resubmit the NDA, addressing the deficiencies identified in the Complete Response Letter, before mid-2015.
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Source: press release, 8/05/13. http://phx.corporate-ir.net/phoenix.zhtml?c=121590&p=irol-newsArticle&ID...

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DURECT Announces Update on Remoxy®

CUPERTINO, Calif., May 10, 2013 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that Pfizer has provided an update on Remoxy as part of their Form 10-Q filing. Pfizer's disclosure is as follows: "In 2005, King Pharmaceuticals, Inc. (King) entered into an agreement with Pain Therapeutics, Inc. (PT) to develop and commercialize Remoxy. In August 2008, the FDA accepted the NDA for Remoxy that had been submitted by King and PT. In December 2008, the FDA issued a "complete response" letter. In March 2009, King exercised its right under the agreement with PT to assume sole control and responsibility for the development of Remoxy. In December 2010, King resubmitted the NDA for Remoxy with the FDA. In June 2011, we and PT announced that a "complete response" letter was received from the FDA with regard to the resubmission of the NDA. We have been working to address the issues raised in the letter, which primarily relate to manufacturing. We met with the FDA in March 2013 to discuss our plan to address the June 2011 "complete response" letter. We received written guidance from the FDA in May regarding required next steps, including additional clinical studies, to address the letter. Based on this guidance, we are considering our options with respect to Remoxy. If we elect to continue development of Remoxy, we would not expect to submit a response to the "complete response" letter before mid-2015."

We understand from Pfizer that additional clinical studies are necessary and include, in part, a pivotal bioequivalence study with the modified formulation to bridge to the clinical data conducted with the original formulation, as well as an abuse potential study with the modified Remoxy formulation.
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Source: press release, 5/10/13. http://phx.corporate-ir.net/phoenix.zhtml?c=121590&p=irol-newsArticle&ID...

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James E. Brown, D.V.M., President and CEO, commented on the progress being made by Pfizer in preparing the submission for the Complete Response Letter for Remoxy. He stated, "Pfizer has a world class team working on REMOXY with expertise in manufacturing quality assurance and regulatory affairs. The program is in good hands to complete what is needed for resubmission of the NDA. Pfizer met with the FDA on March 28 to discuss their resubmission plan and in an answer to a question on their pain portfolio during their first quarter call Pfizer stated the following; That they had a productive meeting with the FDA in March, that the guidance on the meeting will inform Pfizer our next steps in addressing the issues raised by the FDA in the Complete Response Letter and lastly Pfizer also stated they believe there is a path forward for Remoxy and they will publicly communicate further details over the upcoming quarters."
Source: Q1 2013 earnings conference call, 5/02/13.

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Remoxy (DUR)AnesthesiologyPain management (Tamper resistant)Opioid analgesick-opioid receptor agonist

Mechanism of action: Remoxy is an oral, long-acting oxycodone gelatin capsule, formulated to resist common methods of prescription drug misuse and abuse. Remoxy is in development for the treatment of moderate to severe chronic pain.

Phase of Development: Filed

Event Type: Regulatory FDA: PDUFA DATE

Dates: 2016-09-25

Results:

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DURECT's Licensee Pain Therapeutics Receives Complete Response Letter from FDA for REMOXY® ER (oxycodone) Extended-Release Capsules CII
CUPERTINO, Calif., Sept. 26, 2016 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced that its licensee, Pain Therapeutics (Nasdaq: PTIE) has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Pain Therapeutics' New Drug Application (NDA) for REMOXY® ER (oxycodone) extended-release capsules CII. Based on its review, the FDA has determined that the NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.

In a press release issued this morning by Pain Therapeutics, Pain Therapeutics states that "The CRL focuses on the abuse-deterrent properties of REMOXY ER and proposed drug labeling. The CRL makes no mention of clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior Complete Response Letter."

The announcement continues that "Pain Therapeutics is evaluating the CRL and plan further discussions with the FDA. The CRL specifies additional actions that are needed in order to obtain approval of REMOXY ER with label claims against three routes of abuse (i.e., injection, inhalation and snorting). These actions may take approximately a year to conduct and may cost approximately $5MM, pending discussions with the FDA and outside clinical/regulatory consultants."

In addition, the Pain Therapeutics provides the following details of the Complete Response Letter (CRL):

"The CRL focuses on the actions and studies that are needed in order to obtain approval of REMOXY ER with label claims on three routes of abuse (i.e., injection, inhalation and snorting). In conducting the following studies, we will generally compare REMOXY ER vs. one or more commercially available oxycodone ER drug product:

To support a potential drug label claim against abuse by injection: 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 potential drug label claim against abuse by inhalation: Repeat a volatilization study using the same thickness for each drug to increase surface area.
To support a potential drug label claim against abuse by snorting: Conduct an intranasal abuse potential study in human volunteers (i.e., not the animal data we had submitted) with drug applied directly inside the human nasal cavity.
In addition, we had proposed in the REMOXY NDA a label claim against abuse by chewing. Our proposal was based on clinical results of an oral human abuse potential study that met all four co-primary endpoints with statistical significance and that also met several, but not all, secondary endpoints. The CRL asks us to submit a revised proposed label to indicate results of this study do not support a label claim against abuse by chewing."

In December 2002, DURECT licensed to Pain Therapeutics the exclusive right to develop and commercialize on a worldwide basis REMOXY ER and other specified opioid analgesics utilizing DURECT's ORADUR extended-release, abuse-deterrent technology. Under the terms of that license, Pain Therapeutics funds the development program including reimbursing DURECT for formulation and other work performed for Pain Therapeutics. DURECT may also receive additional payments if certain development and regulatory milestones are achieved. DURECT is eligible to also receive royalties of between 6.0% to 11.5% of net sales if REMOXY ER is commercialized, and may receive additional income from the sale of key excipients supplied by DURECT for use in the manufacture of REMOXY ER.
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Source: press release, 9/26/16. http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID...

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