BDSI said the shutdown, which followed the US Food and Drug Administration’s (FDA) discovery of cGMP violations in process controls at Aveva’s plant in Miramar, Florida, was not related to the CMOs production of ONSOLIS.
A warning letter posted on Aveva’s website at the time explained that the firm “failed to conduct an investigation into out-of-specification (OOS) potency results for adhesive laminate used in the production of its clonidine patches.”
Al Medwar of BDSI told Outsourcing-Pharma that although the Aveva shut down lasted for about three months, “due to adequate supplies, there was no disruption to sales in the US.”
However, he said it did result in a “short delay” to ONCOLIS’ commercial launch in Canada which was due to take place in the third quarter this year in partnership with Meda Pharmaceuticals and Valeant.
BDSI now estimates that supplies of the drug to support the Canadian launch will be available by March 2011.
According to Medwar, “the resumption [of manufacturing at Aveva] also means there will be no impact on ONSOLIS sales elsewhere.”
He confirmed that BDSI will continue to work with Aveva adding: “We have full confidence in their ability and the products they produce” and emphasizing that “they were not shut down by the FDA; they voluntarily closed to address some concerns.”
ONSOLIS, or fentanyl buccal soluble film, has been approved in the US, Canada and in Europe where it is marketed as BREAKYL. The opioid analgesic is used to treat spikes of pain experienced by adults who already take an opioid medicine for constant cancer pain.