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.

Use of this compound has been evaluated in multiple clinical trials that have demonstrated the ability of Adlea to provide site-specific local pain relief without some of the systemic side-effects associated with opioid-based pain medications.

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
  • No opioid-like side effects
  • Activity 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 created by the limitations and side effects of currently approved opioid-based pain treatments and the large and growing number of patients who require advanced pain management.

Learn more about the market potential for Adlea

Potential Pathways for Approval

Post-surgical 56.7 MM patients
      Total Knee Replacement 470,000 patients
      Hip Replacement 250,000 patients
      Arthroscopic Shoulder Surgery 485,000 patients
End-stage Osteoarthritis of the Knee (OA) 1.1 MM patients
Tendonitis of the Elbow 1.25 MM patients
Post-traumatic Neuropathic Pain 1.2 MM patients

Adlea Clinical Summary

We have designed a series of Phase 2/3 pivotal trials to confirm the safety and efficacy of Adlea observed to date, as well as further define the clinical activity and optimum dosing of this promising product candidate. We anticipate commencing these studies in 2007 with our near-term focus in two areas: the use of Adlea to treat moderate to severe post-surgical pain and osteoarthritis.

This strategy was explained in detail in our press release dated January 8, 2007.

Anesiva Announces Clinical Plan for Pivotal Testing of Adlea:

  • Two studies in patients undergoing total knee replacement surgery consisting of a pivotal Phase 3 trial and a Phase 2 study to evaluate a higher dose of Adlea
  • Two Phase 2 studies in large joints other than total knee replacement surgery consisting of one study in patients undergoing arthroscopic shoulder surgery and another in hip replacement surgery, and
  • Phase 2 trial in patients with osteoarthritis of the knee

Data from multiple clinical studies of Adlea to date have already demonstrated the ability of Adlea to reduce pain associated with a number of debilitating conditions, including:

  • post-surgical pain following orthopedic procedures, such as total knee replacement and bunionectomy
  • musculoskeletal pain associated with end-stage osteoarthritis of the knee
  • musculoskeletal pain due to tendonitis of the elbow
  • post-trauma neuropathic pain in interdigital neuroma

Summary of clinical data from studies of Adlea

Adlea – Novel Mechanism of Action

Long-lasting "noxious pain" is transmitted in the body by C neurons, a type of nociceptor (pain sensing nerve), and is associated with longer-term, dull, aching, throbbing pain. In contrast, A neurons transmit immediate "adaptive pain," such as that experienced milliseconds after slamming your fingers in a door.

Adlea is a TRPV1 agonist based on capsaicin and acts as a specific C-neuron anesthetic to relieve pain. Administered locally to the site of pain, Adlea has been shown to provide site-specific pain relief by binding to the TRPV1 receptors, which are found on nociceptors. In normal humans and mammals, TRPV1 receptors are expressed only on nociceptors, predominantly C neurons. In clinical trials, Adlea has not been shown to have an adverse effect on normal sensation such as temperature or touch.