5 February 2019 - Going Forward, We Will Be Silent Regarding Future Expectations for REMOXY.

Pain Therapeutics today announced feedback from a meeting held on 31 January 2019 with the U.S. FDA regarding the drug candidate, Remoxy ER. Remoxy is the trade name for a new type of abuse-deterrent, extended-release gel formulation of oxycodone (CII) with physical/chemical properties intended to deter abuse. As previously disclosed, we requested this meeting to resolve disagreement around comments and conclusions made by FDA in 2018 during a regulatory review of a new drug application for Remoxy.

During this meeting, we learned that i) FDA denies making math errors, material mistakes or misrepresentations during a June 2018 Advisory Committee Meeting for Remoxy, despite clear evidence to the contrary; ii) comparator data is irrelevant for the evaluation of abuse-deterrent properties, despite FDA written guidance which explicitly states the opposite; and (ii) that we would need to rely on the Freedom of Information Act to access additional data generated by FDA with Remoxy. As a result of our recent meeting with FDA, we believe we are no closer today to product approval than we were over a year ago.

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