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Pain Therapeutics, Inc.

Partner : Pfizer, Durect

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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FDA ACCEPTS REMOXY NDA FOR REVIEW, SETS PDUFA DATE OF SEPTEMBER 25, 2016

- Company Will Host Conference Call on Wednesday, April 13th, 8:30am EDT -

- Guest Speaker Invited to Discuss REMOXY's Target Market -

AUSTIN, Texas, April 12, 2016 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today that the U.S. Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) resubmission for REMOXY®, an abuse-deterrent formulation of extended-release oxycodone (CII) capsules, is sufficiently complete to permit a substantive review. September 25, 2016 is the target action date under the Prescription Drug User Fee Act (PDUFA).

"The acceptance of the REMOXY NDA marks another important milestone for Pain Therapeutics," said Remi Barbier, President and Chief Executive Officer of Pain Therapeutics. "We are grateful to the people, partners and patient investors who are helping to make this innovation a reality. We look forward to working closely with the FDA during the regulatory review process."

About the Conference Call
Pain Therapeutics will host a conference call on Wednesday, April 13th at 8:30am EDT to discuss the REMOXY NDA and this drug candidate's target market. Guest speaker Mr. John LaLota, a consultant to Pain Therapeutics, will join the call. Mr. LaLota has over 25 years of management experience in the analgesic marketplace. Having directed 6 major launch campaigns in the analgesic area, he is recognized as a foremost expert in the commercialization of analgesics. Major brands under Mr. LaLota's direction during his tenure at Johnson & Johnson, Wyeth and Knoll included the pain drugs Duragesic®, Orudis® and Vicodin®. Under his commercial direction, all three drugs became market leaders within 2 years of launch.

To participate in this conference call please dial toll-free 1-877-407-4018 (U.S.) or 1-201-689-8471 (international).
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Source: press release, 4/12/16. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=964739

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Pain Therapeutics Resubmits REMOXY New Drug Application to the U.S. Food and Drug Administration
REMOXY NDA Has Priority Review
AUSTIN, Texas, March 29, 2016 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today that it has resubmitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for REMOXY®, an abuse-deterrent formulation of extended-release oxycodone (CII) capsules. Pain Therapeutics expects 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.

REMOXY is a proprietary drug developed and owned by Pain Therapeutics. The drug candidate's proposed indication is for "the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate".

Pain Therapeutics specifically developed REMOXY to make oxycodone difficult to abuse yet provide 12 hours of steady pain relief when used appropriately by patients. In particular, REMOXY's thick, sticky, high-viscosity formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking. Pain Therapeutics owns exclusive, worldwide rights to REMOXY.
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Source: press release, 3/29/16. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=962429

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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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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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"We continue to believe our lead drug candidate, REMOXY, is on-track for an NDA re-filing in mid-2015 by Pfizer," said Remi Barbier, Chairman, President & CEO of Pain Therapeutics. "FENROCK expands our pipeline and is consistent with our strategy to eventually develop drugs in four major categories of pain management: mild, moderate, moderate-severe and severe pain. There is no change to our financial guidance for 2014, as FENROCK's development costs are already reflected in our projected cash use of about $12 million in 2014."
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Source: press release, 9/26/14. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=873225

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AUSTIN, Texas, Feb. 4, 2014 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported financial results for 2013 and provided guidance for 2014. Net profit in 2013 was $31.5 million, or $0.70 per diluted share, compared to a net loss in 2012 of $3.4 million, or $0.08 per share.

"We are excited about what lies ahead for PTIE in 2014," said Remi Barbier, President & CEO. "We'll be watching the progress of REMOXY carefully over the next few quarters, as Pfizer has stated an intent to refile an NDA mid-2015. Any moves towards risk-reduction around this drug candidate may accelerate our corporate strategy to transition from purely an R&D company to a mix of R&D and product revenue. Based on the clinical and commercial profiles of REMOXY, and potential upside of our early-stage assets, I believe 2014 may be a pivotal year for us."
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Source: press release, 2/04/14. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=823035

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PAIN THERAPEUTICS REPORTS PFIZER ELECTS TO CONTINUE DEVELOPMENT OF REMOXY(R)

— No Change to Program Timelines and No Change to REMOXY Deal Economics —

— Commercial Rights to Three Drug Assets Revert to Pain Therapeutics —

AUSTIN, Texas, Oct. 22, 2013 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported Pfizer Inc. (NYSE:PFE) has informed us that, having achieved technical milestones related to manufacturing, they will continue the development program for REMOXY® (oxycodone) Extended-Release Capsules CII.

We also were informed that, following guidance received from the U.S. Food and Drug Administration (FDA) earlier this year, Pfizer 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.

The FDA did not require any further drug efficacy trials. As previously disclosed, the complete response submission is not expected to occur prior to mid-2015.

REMOXY DEAL ECONOMICS ARE UNCHANGED

Pfizer is our exclusive, worldwide partner for REMOXY (except as to Australia/New Zealand). We are eligible to receive from Pfizer a $15.0 million payment upon FDA approval of REMOXY. After commercial launch, we will receive from Pfizer a royalty of 20% of net sales of REMOXY in the United States, except as to the first cumulative $1.0 billion in net sales, which royalty is set at 15%. The royalty rate outside the U.S. is 10%.

In addition, we will also receive from Pfizer a supplemental payment of 6% to 11.5% of net sales, depending on the range of total dollar sales in each year. This supplemental payment is tied to the full amount of our financial obligations to Durect Corporation (Nasdaq:DRRX), our exclusive supplier of certain excipients.

THREE ASSETS REVERT BACK TO US

Pfizer has returned to us all rights with respect to abuse-resistant formulations of hydrocodone, hydromorphone and oxymorphone. These drug assets now vest exclusively in PTI without any royalty or other obligation to Pfizer. We are now free to develop and commercialize these assets on our own or with a licensee of our choice, and may do so without notice or approval from Pfizer. Investigational New Drug (IND) applications for all three drug assets are in place with FDA. We have not yet made a decision to develop or to out-license the three drug assets.
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Source: press release, 10/22/13. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=798941

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Pain Therapeutics Files Form 8-K Regarding Correspondence From Pfizer, Inc.

AUSTIN, Texas, May 10, 2013 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today that yesterday it received correspondence from Pfizer, Inc. (NYSE:PFE).

The company furnished the correspondence with the Securities and Exchange Commission pursuant to the submission of a Current Report on Form 8-K.
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Source: FORM 8K, 5/10/13. http://investor.paintrials.com/secfiling.cfm?filingid=1171843-13-1963

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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...

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Remoxy (PTI)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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COMPLETE RESPONSE LETTER FOR REMOXY®

Company Will Host Conference Call Monday, September 26th at 9:00am EDT
AUSTIN, Texas, Sept. 26, 2016 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on the resubmission of its new drug application (NDA) for REMOXY ER (oxycodone capsules CII). The CRL informs that REMOXY ER cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.

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.

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.

Conference Call
Pain Therapeutics will host a conference call on Monday, September 26th at 9:00am Eastern time to discuss the Complete Response Letter. To participate in this conference call please dial toll-free 1-877-407-4018 (U.S.) or 1-201-689-8471 (international).

Those interested in listening to the conference call live via the internet may do so by visiting www.paintrials.com. About two hours following the live call, a replay of the conference call will be available by phone through October 3, 2016. To listen to a replay of the call, please dial toll-free 1-877-870-5176 (U.S.) or 1-858-384-5517 (international) and press pin number 1212590.

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.
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Source: press release, 9/26/16. http://investor.paintrials.com/releasedetail.cfm?ReleaseID=990817

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