The New Jersey-headquartered pharma firm announced this week that the US Food and Drug Administration (FDA) sent a CRL regarding its new drug application (NDA), CAM2038.
According to the firm, “the FDA has requested additional information in order to progress the application forward,” and did not ask Braeburn for additional clinical studies.
The candidate consists of the opioid buprenorphine, designed to treat opioid use disorder (OUD) in adults. While buprenorphine is used in a number of marketed oral products for OUD – including Reckitt Benckiser’s Subutex – CAM2038 is being developed as a subcutaneous depot giving the patient a weekly or monthly sustained-release of the drug.
In 2016, the company announced it was constructing a $20m R&D and manufacturing site in North Carolina to support the candidate
According to Braeburn the continuous drug delivery system – developed by Braeburn’s partner Titan Pharmaceuticals – can lead to reduced risk of abuse and increased patient compliance.
The platform consists of a small, solid implant made from a mixture of ethylene-vinyl acetate (EVA) and the drug substance. This results in a solid matrix injected subcutaneously into the arm of an outpatient, and removed in a similar manner at the end of the treatment period.
Braeburn said in a statement that it is working to address the FDA’s requests in a timely manner. A spokesperson could not give in-Pharmatechnologist any further information when contacted.
Complete response letters are sent by the US FDA at the end of a review period to inform a company that new drug applications (NDAs) – and soon abbreviated new drug applications (ANDAs) – have not been approved.
This could be for a number of reasons ranging from an application lacking adequate data to specific deficiencies in the production process.
CRLs are rarely made public, but FDA commissioner Scott Gottlieb said last week the Agency was looking “to explore whether it would be possible – under existing statutory authority or through a change in the governing law – to release additional information from complete response letters (CRLs) related to clinical safety and efficacy that could have significant public health value.”
As part of a transparency drive, Gottlieb said that while “releasing all the CRLs would be administratively burdensome … and not all the letters have information that would directly inform clinical practice,” some letters contain information that could be directly relevant to patients and “releasing this information could enhance patient safety, by reducing the number of potentially futile trials, and spare patients exposure to potential risks without the prospect of a likely benefit.”