FDA Gives Pharma a Boost to Develop OTC Opioid Overdose Antidote

(Bloomberg) -- The Food and Drug Administration is trying to make it easier for drug companies to make nonprescription versions of opioid overdose antidote naloxone.

The agency has created sample consumer-friendly labels drugmakers can use when they apply for permission to sell over-the-counter naloxone as a nasal spray or auto-injector, FDA Commissioner Scott Gottlieb said in a statement on Thursday. This is the first time the agency has created and tested a label for a drug consumers can purchase directly, he said.

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  • Emergent BioSolutions Inc. sells a prescription naloxone nasal spray known as Narcan. Opiant Pharmaceuticals Inc. developed the spray and collects royalties on it. Kaleo Inc. markets prescription Evzio, a naloxone auto-injector.
  • Most states allow naloxone to be dispensed without a prescription but pharmacist participation has been spotty.
  • Gottlieb said a requirement for testing showing that consumers can read a label and use a nonprescription drug properly has been a barrier for companies that want to sell over-the-counter naloxone. Companies will still have to ensure consumers understand parts of the label that are product-specific.

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  • The move is part of a wider effort to reduce overdose deaths. The FDA has explored limiting the number of opioids per prescription. It has also required more training for medical professionals on prescribing the painkillers.
  • Opioids were involved in 47,600 overdose deaths in 2017, or almost 68 percent of all fatal overdoses, according to the Centers for Disease Control and Prevention.

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