According to the company, the trial also achieved a key secondary endpoint of reducing opioid use for Adlea versus placebo (p=0.012) over the four to 32 hour period. Adverse events were similar for both active treatment and placebo groups.
Anesiva has determined that it will cease further commitments to support Zingo commercialization as a result of continued manufacturing challenges and the need to recall the product in the field due to a potential non-safety related shelf life issue from a lot of unreleased product. Anesiva plans to seek a device-oriented partner for this asset. The company will also seek to license rights to the underlying drug delivery technology to third parties for use with other medications.
The company plans to meet with its joint venture partners in China to discuss the future of the relationship. Anesiva will restructure, suspend or cancel Zingo distribution agreements for ex-US territories. In order to wind down ongoing product support obligations, Anesiva will process the withdrawal of Zingo devices from the US supply chain.
As a result of the decision to cease Zingo commercial operations, the company has agreed to work with its lenders to accelerate repayment of its outstanding $20 million loan. In order to preserve its capital, the company will reduce its staffing to approximately 15 employees and reduce monthly expenditures to approximately $2 million, pending the results of the Adlea Phase III trial in total knee replacement surgery.
Michael Kranda, president and CEO of Anesiva, said: “These are difficult but necessary decisions that set a new foundation upon which to rebuild value for Anesiva’s stock holders. We look forward to the results of the Adlea Phase III trial in total knee arthroplasty, and pursuing partnering opportunities for this promising product candidate.”