POSIDUR™ (SABER® - Bupivacaine) is a long-acting bupivacaine formulation being developed for the treatment of post-surgical pain. It is administered during surgery to the surgical site, where it continuously releases therapeutic levels of bupivacaine in a controlled fashion, providing up to 72 hours of uninterrupted local analgesia.
According to data published by the Center for Disease Control and Prevention, there are approximately 72 million ambulatory and inpatient procedures performed in the United States. Epidemiological studies indicate that up to 100% of surgical patients experience postoperative pain, with 50-75% reporting inadequate pain relief. The current standard of care for post-surgical pain includes oral opiate and non-opiate analgesics, transdermal opiate patches and muscle relaxants. While oral analgesics can effectively control post-surgical pain, they commonly cause side effects such as drowsiness, constipation, cognitive impairment and other possible side effects. Effective pain management can be compromised if patients fail to adhere to recommended dosing regimens because they are sleeping or disoriented. Post-surgical pain can be treated effectively with local analgesics; however, the usefulness of current conventional medications is limited by their short duration of action.
Potential Product Benefits:
||Reduction in use of narcotics for post operative pain, which should in turn reduce opioid-related side effects such as nausea, vomiting, GI upset, cognitive impairment, etc.
|Improve post-operative analgesia in a wide variety of procedures.|
|Reduce post-operative recovery time.|
|Potential to reduce the duration of hospital stays and may allow some inpatient procedures to become outpatient procedures.|
|Reduce the amount of time surgeons, nurses and other hospital staff spend managing post-surgical pain.|
Current Clinical Status
A total of 15 clinical trials in subjects undergoing various surgical procedures have been conducted with POSIDUR. In all, 1,060 subjects have been studied in the POSIDUR Phase 2 and 3 clinical development program, of which 668 have been treated with POSIDUR, 268 with SABER-Placebo (SABER vehicle without drug), and 124 with bupivacaine HCl solution. In July 2012, we completed pre-NDA communications with the FDA regarding POSIDUR.
In April 2013, we submitted a new drug application as a 505(b)(2) application, which relies in part on the FDA’s findings of safety and effectiveness of a reference drug. On February 12, 2014, the FDA issued a Complete Response Letter for POSIDUR. Based on its review, the FDA has determined that they cannot approve the NDA in its present form, stating the NDA does not contain sufficient information to demonstrate that POSIDUR is safe when used in the manner described in the proposed label, and the FDA has indicated that additional clinical safety studies need to be conducted. We had a face-to-face meeting with the FDA in September 2014 to discuss what needs to be done to address the issues cited in the Complete Response Letter. As a result of this meeting and based on subsequent communications with the FDA, we have submitted to the FDA a protocol synopsis for a soft tissue Phase 3 clinical trial designed to generate the efficacy and safety data required by the FDA for product approval. We are awaiting feedback to that protocol synopsis. There can be no assurance we may be able to adequately address all of FDA’s concerns regarding the POSIDUR NDA or there could be a delay in addressing such concerns, the FDA may not grant regulatory approval of POSIDUR, there is a risk of potential adverse effects arising from additional testing or use of POSIDUR, and the data that we have generated or may generate may not be deemed sufficient by FDA or other regulatory agencies to support regulatory approval of POSIDUR.
To review data on POSIDUR (also known as SABER® - Bupivacaine), click here.