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Regulatory Focus™ > News Articles > FDA Issues Untitled Letter for Website Promotion of an Opioid 10 Days Before PDUFA Date

FDA Issues Untitled Letter for Website Promotion of an Opioid 10 Days Before PDUFA Date

Posted 14 September 2016 | By Zachary Brennan 

FDA Issues Untitled Letter for Website Promotion of an Opioid 10 Days Before PDUFA Date

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) is calling on Durect and Pain Therapeutics to pull promotional materials on their websites for their unapproved Remoxy (oxycodone) extended-release capsules as the sites incorrectly suggest that the investigational new drug is safe and effective.

The letter, dated 9 September for Cupertino, CA-based Durect and Austin-based Pain Therapeutics, comes a little more than two weeks before FDA is supposed to decide on whether to approve the opioid for the third time, according to an SEC filing.


Pain Therapeutics first submitted its new drug application (NDA) for Remoxy to FDA in June 2008, and in August 2008 the FDA accepted the NDA and granted priority review. Four months later, FDA issued a Complete Response Letter (CRL) for the NDA, calling for additional non-clinical data.

The NDA was resubmitted two years later, in December 2010, and in February 2011, Pain Therapeutics’ partner in developing the opioid, King Pharmaceuticals, was acquired by Pfizer for more than $3 billion. In June 2011, Pfizer received another CRL for the resubmitted NDA.

In October 2014, Pfizer decided to discontinue development of Remoxy and return all rights to Pain Therapeutics. Almost two years later, in March 2016, Pain Therapeutics announced that it had resubmitted an NDA to FDA.

Noting 25 September as the target action date under the Prescription Drug User Fee Act (PDUFA), Pain Therapeutics was informed in July 2016 that FDA had determined that an advisory committee meeting was unnecessary for the opioid, and that the hearing would not be held as previously planned on 5 August.

“Pain Therapeutics also stated that the FDA advised them that the regulatory review remains active and is on-going, and the PDUFA date of September 25, 2016 remains unchanged,” the SEC filing says.

Untitled Letter

But before that decision comes, FDA has criticized both Durect and Pain Therapeutics’ websites for containing suggestions that Remoxy ER is safe and/or effective for the purposes for which it is being investigated and that “Remoxy resists injection or snorting.”

The agency notes an “indirect statement” on the website saying that the product is not approved — “the most information the webpage provides on this point” — and the statement “is only visible to website visitors on the product webpage who make the effort to expand the ‘Current Status’ heading, and even then, the statement cannot be viewed at the same time as the prominent assertions regarding Remoxy ER’s properties that are viewed under the ‘Potential Benefits’ heading that precedes the ‘Current Status’ heading. In total, these presentations neither adequately convey that the product is unapproved, nor sufficiently mitigate impressions conveyed by the design of, and claims on, the webpage.”

While noting the opioid epidemic wreaking havoc across the US, FDA adds that “for each of the seven extended-release/long-acting (ER/LA) opioids that FDA has, to date, approved with labeling describing the particular abuse-deterrent properties established for that product, labeling has included additional information not presented on the websites for Remoxy ER addressed above, to clarify that even where abuse deterrent properties do exist, opioid drugs such as oxycodone still expose users to the risks of addiction, abuse, and misuse.”

FDA is seeking a written response to the letter on or before 22 September “explaining plans for discontinuance of materials such as those identified in this letter.” This is the fourth untitled letter issued by OPDP in 2016 but the second issued in the last month. Durect did not respond to a request for comment.

Untitled Letter

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