Post-surgical Pain

The estimated 56.7 million patients in the United States who undergo surgery every year have a significant need for new analgesic options. Existing agents have a short duration of action and are taken as needed, which can result in a limited window of efficacy and subsequent analgesic gaps and breakthrough pain for patients. Common side effects of existing systemic pain management alternatives, such as opioids, include cognitive impairment, nausea, vomiting, constipation, respiratory depression, pain-sedation cycles, and the potential for dependence. Opioid side effects can also extend hospital stays, increase hospitalization costs due to the additional healthcare management required for administration and interfere with rehabilitation.

A product candidate such as Adlea, where a single local application of the compound could block the noxious pain associated with surgery, may provide superior analgesia without adding to the systemic side effects commonly associated with opioid use. A reduction in pain may allow the patient to be ambulatory sooner, maximize rehabilitation with improved mobility and potentially reduce hospital length of stay.

Total Knee Replacement and Large Joint Surgery

In 2005, it is estimated that in the United States 565,000 patients underwent total knee replacements a number that is expected to grow to approximately 3.5 million by the year 2030. In addition, in 2005, U.S. patients underwent an estimated 287,000 bunionectomy surgeries, 250,000 hip replacement surgeries and 488,000 arthroscopic shoulder surgeries.

Like most large joint surgeries, total knee replacements are a significant source of pain for patients due to the invasive nature of these procedures, which involve the dissection of skin and muscle in addition to cutting of bone from tibia, femur and sometimes patella. Immediately following surgery, patients begin intensive rehabilitation in the hospital and continue it for several weeks to months to ensure mobility and function of the new joint. It is the combination of these factors that makes total knee replacement one of the most painful orthopedic procedures.

Bunionectomy Surgery

A bunionectomy is a surgical procedure to align the bones of the toe joint and excise the bunion. A bunion is an enlargement of the joint at the base of the toe caused by the misalignment of the toe joint. It is usually a result of inflammation and irritation from poorly fitting (narrow and tight) shoes and is a condition that can be exacerbated by excessive standing or running. Bunionectomies are often performed as outpatient procedures, enabling patients to go home the same day of their surgery. An estimated 287,000 bunionectomy surgeries are performed in the United States each year.