Acura Pharmaceuticals has received $20m milestone payment from Pfizer, following Pfizer's OXECTA (Oxycodone HCl, USP) Tablets CII new drug application (NDA) approval by the US Food and Drug Administration (FDA).
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OXECTA, an immediate-release oxycodone HCl medicine, is indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.
OXECTA applies AVERSION Technology, which is designed to discourage common methods of tampering associated with opioid abuse and misuse.
The AVERSION Technology is a composition of commonly used pharmaceutical ingredients.
Pfizer has licensed three additional AVERSION Technology products from Acura, including oxycodone HCl/acetaminophen tablets and hydrocodone bitartrate/acetaminophen tablets in the US, Canada and Mexico.
Acura is eligible to collect from Pfizer an additional $3m for Pfizer’s achievement of certain non-US regulatory milestones for OXECTA and up to $23m for Pfizer’s achievement of certain regulatory milestones for each of the 3 other unapproved licensed products.
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