Moderate-To-Severe Pain
Millions of patients in the United States experience acute moderate-to-severe pain in surgical, emergency room, and intensive care settings. Additionally, almost 10% of the US population experiences chronic moderate-to-severe pain from cancer, arthritis, back pain, and other causes. The need for new analgesics with reduced side effects compared to currently available narcotics is obvious. Patients have become much more aggressive in their demands for adequate pain relief, and regulatory agencies are focusing on the adequate provision of analgesia to patients in need. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has mandated that all US hospitals and healthcare facilities assess the adequacy of pain management for each patient on a daily basis. The American Pain Society has subsequently declared pain to be the fifth vital sign. There is also a focus on the need for analgesics with reduced potential for abuse and dependence.
The current market for acute injectable analgesics in the United States is approximately $300 million, served primarily by intravenous formulations of the generic mu-receptor opioids morphine, fentanyl, and various analogues. The market for chronic opioids in the United States currently exceeds $3.6 billion and is growing in excess of 30% per year. This market is dominated by extended release formulations of generic mu-receptor agonists such as morphine, fentanyl, and oxycodone. The leading products are OxyContin® (extended release oxycodone), with annual US sales of approximately $1.3 billion, and Duragesic® (fentanyl in a transdermal patch), with annual US sales over $500 million.
We believe there is a significant need in both the acute and chronic settings for improved analgesic compounds with reduced side effects.