Adlea™
Long-acting, Non-opioid Analgesic
Adlea (formerly 4975) is a long-acting, non-opioid analgesic drug candidate designed to provide pain relief for weeks to months after a single local application.
Adlea has been evaluated in multiple clinical trials that have demonstrated that it can provide site-specific pain relief without adding to the systemic side-effects associated with other pain medications including opioids. In randomized trials, side effects were similar in patients receiving Adlea or placebo.
We believe the unique characteristics of Adlea and the limitations of currently available pain therapeutics give this product candidate blockbuster potential:
- Powerful analgesia
- Long-acting pain relief (weeks to months after single administration)
- Rapid onset of action
- Local administration with targeted, site-specific action
- Analgesia does not affect other nerve fibers important for motor skills or sensation
Adlea Market Potential
The superior product profile of Adlea has the potential to address the significant unmet medical need in the pain market not satisfied by currently approved pain treatments and the large and growing number of patients who require advanced pain management.
Learn more about the market potential for Adlea
Potential Adlea Applications |
Annual Number |
| Total Knee Replacement | 565,000 |
| Bunionectomy | 287,000 |
| Total Hip Replacement | 250,000 |
| Arthroscopic Shoulder Surgery | 488,000 |
| Moderate to Severe Osteoarthritis of the Knee (OA) | 5 MM |
| Tendonitis of the Elbow | 1.25 MM |
| Interdigital Neuroma | 216,000 |
Adlea Clinical Summary
Anesiva is focused on developing Adlea for acute post-operative pain associated with orthopedic surgeries and moderate to severe osteoarthritis pain. We have designed a series of Phase 2 and Phase 3 pivotal trials to confirm the safety and efficacy of Adlea observed to date, as well as to further define the clinical activity and optimum dosing of this promising product candidate. Data from clinical studies of Adlea to date have demonstrated its ability to reduce pain following orthopedic surgeries as well as joint pain due to moderate to severe osteoarthritis, musculoskeletal pain due to tendonitis of the elbow, and post-trauma neuropathic pain in interdigital neuroma.
Adlea is currently in two pivotal Phase 3 trials: for pain management following total knee replacement surgeries and for the management of pain following bunionectomy surgeries. These trials, along with supportive Phase 2 trials in other surgical settings, are intended to support a broad product label for the management of post-operative pain associated with orthopedic surgery. Adlea has demonstrated statistically significant pain reduction in Phase 2 trials in both knee replacement and bunionectomy surgeries.
The Phase 3 total knee replacement trial will enroll 214 patients and the bunionectomy trial is designed to enroll 300 patients. In both trials, patients are randomized to receive either a single dose of Adlea or placebo into the surgical site prior to closure. The primary efficacy endpoint of both trials is a time-weighted pain score (using a standard 0 - 10 numerical rating system of pain intensity). In addition, the studies will evaluate opioid use following surgery. The safety of Adlea in both settings also will be evaluated.
Anesiva also has ongoing a Phase 2 trial of Adlea for pain management following total hip replacement surgeries, and plans to initiate a Phase 2 trial in arthroscopic shoulder surgeries.
Summary of clinical data from Adlea studies
Adlea — Novel Mechanism of Action
Adlea is a long-acting, non-opioid drug with the potential to provide pain relief for weeks to months after a single localized treatment. Its novel mechanism of action results in site-specific efficacy intended to avoid the unwanted side effects associated with systemically administered analgesic drugs such as opioids and NSAIDs.
Adlea is a highly purified form of capsaicin (derived from chili peppers) that acts primarily on TRPV-1 receptors residing on the C-fiber neurons which transmit long-term pain by binding to and desensitizing these pain receptors. This leads to a prolonged, reversible and localized desensitization of the pain fibers. The drug generally has a short half-life of 1 to 2 hours, and is undetectable in the blood after 24 hours. In clinical trials, Adlea has not been shown to have adverse effects on normal sensation such as temperature or touch.
Adlea’s short duration of systemic exposure relative to the longer duration of analgesia may offer a safe, additive treatment option in the management of post-surgical orthopedic pain. In clinical trials to date, adverse events have been similar in patients receiving Adlea or placebo. Adlea is also in development for the treatment of pain associated with moderate to severe osteoarthritis.
