US-based specialist pharmaceutical company AcelRx has begun its Phase III IAP312 study of Zalviso to treat moderate-to-severe acute post-operative pain in adult patients in a hospital setting.
Zalviso is designed to deliver sufentanil, a high-therapeutic index opioid formulated in a patented, non-invasive sublingual dosage form.
The IAP312 was requested by the Division of Anesthesia, Analgesia and Addiction Products of the US Food and Drug Administration (FDA) and has been designed as multicentre, open-label study.
It will enrol approximately 315 hospitalised, post-operative patients who will self-administer sublingually tablets containing 15mg of sufentanil using Zalviso.
The study intends to determine the safety and efficacy of Zalviso and its usability.
AcelRx co-founder and chief medical officer Dr Pamela Palmer said: "We designed Zalviso to have characteristics that would offer patients and healthcare providers benefits over IV morphine, the current standard of care for the treatment of moderate-to-severe acute pain in hospitalised patients.
"The initiation of IAP312 is an important milestone, as it represents what we expect to be the last step in the Zalviso clinical development programme, bringing a product that we believe can offer patients a new option for treating their moderate-to-severe acute pain, closer to market."
IAP309 was one of the previously conducted Phase III studies of Zalviso and has validated its superiority to intravenous (IV) PCA morphine, based on the primary endpoint of Patient Global Assessment method of pain control comparison over the 48-hour trial period (PGA48).
IAP310 and IAP311 have demonstrated the efficacy of Zalviso in managing post-operative pain compared to placebo-treated patients.