Braeburn resubmits opioid addiction candidate to US FDA

29-May-2018 - Last updated on 29-May-2018 at 16:15 GMT

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Braeburn has resubmitted its opioid use disorder candidate following the US FDA’s rejection in January.

Braeburn has again submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its investigational sustained-release subcutaneous buprenorphine injection CAM2038.

The firm received a complete response letter (CRL) for CAM2038, designed to treat opioid use disorder, from the FDA in January this year.

According to Braeburn, the agency had requested additional information – and not additional clinical studies – which it has included in the latest submission.

CAM2038 is administered subcutaneously by a small needle in a low volume and does not require refrigeration, a spokesperson told us.

The candidate "contains buprenorphine which, due to its partial opioid agonist properties, has a ‘ceiling effect’ where increasing doses result in levelling off unwanted opioid effects, such as respiratory depression,” we were told.

According to the firm, there "remains a need for an effective weekly and monthly injectable treatment option that can be individualized to support patients throughout their recovery – from initiation and stabilization, to longer-term maintenance."

“CAM2038, if approved, is the only injectable that can be administered weekly or monthly from the first day of treatment and throughout the recovery journey, thus replacing the need for a daily, oral treatment decision by patients,” said the spokesperson.

Earlier this month, the FDA approved US WorldMeds LLC’s non-opioid treatment Lucemyra – the first non-opioid treatment for the management of opioid withdrawal symptoms.

Lucemyra (Iofexidine hydrochloride) is made by contract manufacturing organisation (CMO) Catalent Pharma Solutions at its Winchester, Kentucky-based facility in the US.