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news.US-based BioDelivery Sciences International (BDSI) has entered into an agreement with Quintiles to provide a range of services to support the expected launch of BUNAVAIL (buprenorphine and naloxone buccal film), BDSI's proposed maintenance treatment for opioid dependence.
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Currently, BUNAVAIL is under review at the US Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) date of 07 June 2014.
If BUNAVAIL is approved, the company intends to launch the product in the latter part of third quarter of 2014.
As part of the deal, Quintiles will offer a range of services to support the launch and subsequent commercialization of BUNAVAIL in the US, including a field sales force.
Quintiles will also be responsible for supporting the recruitment, training and deployment of a competitively sized sales force capable of reaching the physician base treating the majority of patients with buprenorphine for opioid dependence.
Separately, BDSI has entered into an agreement with Ashfield Market Access, which will be responsible for executing a payer strategy aimed at maximizing patient access to BUNAVAIL.
BDSI president and chief executive officer Mark Sirgo said the company has been working with and have formed strong relationships with these two companies over the past year, and in conjunction with them have developed a commercial plan that will support what we believe will be a successful launch of BUNAVAIL in the US later in 2014.
"Both Quintiles and Ashfield Market Access have an excellent history of supporting companies like BDSI in successfully launching and commercializing important new products," Sirgo said.
"We will provide greater details around our plans for the launch of BUNAVAIL as we approach our June 7th PDUFA date and the product’s potential approval."