A New Therapeutic Approach

How It Works
The active molecule in AXS‑02 is a potent inhibitor of the bone‑resorbing cells called osteoclasts. Osteoclasts break down bone by secreting protons or acid. As acid is known to excite pain receptors, the effects of AXS-02 on osteoclasts may reduce pain by suppressing localized over-production of acid in bone. AXS-02 may also inhibit the production of pro‑inflammatory cytokines which have been shown to contribute to pain.

Clinical
AXS-02 is currently in a Phase 3 trial in CRPS. AXS-02 has been granted Fast Track and Orphan Drug Designation by the FDA, and Orphan Medicinal Product Designation by the European Medicines Agency for the treatment of CRPS.

AXS-02 is also in a Phase 3 trial in knee OA associated with BMLs. This trial has received a Special Protocol Assessment (SPA) from the FDA. AXS-02 has been granted Fast Track by the FDA for the treatment of knee OA associated with BMLs.

An additional Phase 3 trial with AXS-02 is planned in CLBP associated with MCs.

Product Pipeline

Indications

Complex Regional Pain Syndrome (CRPS)
CRPS is a disorder characterized by severe, continuous, disabling pain in a limb accompanied by autonomic, sensory, motor, and skin and nail changes. The sensory changes, including allodynia, which is pain invoked by normally non‑painful tactile stimuli, and hyperalgesia, which is greater than normal pain from painful stimuli, are accompanied by movement disorders and joint stiffness. It is estimated that there are approximately 80,000 new cases of CRPS in the United States annually. There is currently no drug approved for the treatment of CRPS.

More about CRPS

Knee Osteoarthritis (OA)
Knee OA is a disorder characterized by bone changes around the knee joint, progressive loss of joint cartilage, joint space narrowing, and eventual total joint failure. Knee OA results in knee pain, significant physical disability, and reduced quality of life. Some patients with knee OA exhibit bone marrow lesions (BMLs). BMLs appear as areas of increased signal intensity on MRI of the knee, and are associated with knee pain, disease severity and disease progression. Results of epidemiological studies suggest that there are approximately 12 million patients in the United States, 50 years of age and older, with symptomatic knee OA, of whom an estimated approximately 7 million have BMLs.

More about knee OA

Chronic Low Back Pain (CLBP)
CLBP is defined as persistent or fluctuating low back pain lasting at least three months. It is a disabling and costly condition that is associated with increased healthcare utilization. Some patients with CLBP exhibit Modic changes (MCs) which are vertebral bone marrow changes that are visible on MRI of the spine. MCs, especially type 1, are associated with low back pain, persistent symptoms and poor outcomes. Results of epidemiological studies suggest that there are approximately 9 million adults in the United States with CLBP, of whom an estimated approximately 1.6 million have type 1 MCs.

More about CLBP