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Capsaicin

Generic Name
Capsaicin
Brand Names
Capzasin Quick Relief, Capzasin-HP, Castiva Warming, Dendracin Neurodendraxcin, Lidopro, Medi-derm, Medi-derm With Lidocaine, Medrox, Qutenza, Rematex, Xoten-C, Zostrix
Drug Type
Small Molecule
Chemical Formula
C18H27NO3
CAS Number
404-86-4
Unique Ingredient Identifier
S07O44R1ZM
Background

Capsaicin is most often used as a topical analgesic and exists in many formulations of cream, liquid, and patch preparations of various strengths; however, it may also be found in some dietary supplements. Capsaicin is a naturally-occurring botanical irritant in chili peppers, synthetically derived for pharmaceutical formulations. The most recent capsaicin FDA approval was Qutenza, an 8% capsaicin patch dermal-delivery system, indicated for neuropathic pain associated with post-herpetic neuralgia.

Indication

The capsaicin 8% patch is indicated in the treatment of neuropathic pain associated with post-herpetic neuralgia. There are multiple topical capsaicin formulations available, including creams and solutions, indicated for temporary analgesia in muscle and join pain as well as neuropathic pain.

Associated Conditions
Back Pain Lower Back, Back pain, Bursitis, Contusions, Inflammatory Reaction caused by Rheumatism, Muscle Cramps, Musculoskeletal Pain, Neuropathic Pain, Osteoarthritis (OA), Pain caused by Rheumatism, Periarthritis, Soft Tissue Injury, Tendinitis, Acute nonspecific tenosynovitis, Articular inflammation
Clinical Trials
Related News

Averitas Pharma Completes Enrollment in Phase III Trial of QUTENZA for Post-Surgical Neuropathic Pain

• Averitas Pharma has finished enrolling 410 patients in its Phase III AV001 trial assessing QUTENZA for post-surgical neuropathic pain (PSNP). • The randomized, double-blind study will evaluate QUTENZA's safety, efficacy, and tolerability over 42 weeks, with topline results expected in Q4 2025. • The primary endpoint is the decrease in average pain intensity at 12 weeks compared to baseline, potentially expanding QUTENZA's US indication. • If successful, Averitas Pharma plans to submit a supplemental new drug application (sNDA) in 2026, addressing an unmet need for non-opioid PSNP treatment.

Averitas Completes Phase III Trial Recruitment of QUTENZA for Post-Surgical Neuropathic Pain

• Averitas Pharma has finished recruiting 410 patients for its Phase III AV001 trial assessing QUTENZA for post-surgical neuropathic pain (PSNP). • The randomized, double-blind study will evaluate QUTENZA's safety, efficacy, and tolerability over 42 weeks, with topline results expected in Q4 2025. • The primary endpoint is the reduction in average pain intensity at week 12 compared to baseline, potentially expanding QUTENZA's US indication. • Averitas plans to submit a supplemental New Drug Application (sNDA) in 2026 if the trial demonstrates positive outcomes for PSNP treatment.

Phase III Trial of Qutenza® for Post-Surgical Neuropathic Pain Completes Enrollment

• Grünenthal and Averitas Pharma have completed recruitment for a Phase III trial (AV001) evaluating Qutenza® (capsaicin) 8% topical system for post-surgical neuropathic pain (PSNP). • The randomized, double-blind trial includes 410 patients and assesses the efficacy, safety, and tolerability of Qutenza® over 42 weeks, with topline results expected in Q4 2025. • The primary endpoint is the reduction in average pain intensity after 12 weeks compared to baseline, with secondary endpoints including long-term pain reduction and quality of life improvements. • Averitas Pharma aims to submit a supplemental new drug application (sNDA) to the FDA in 2026, assuming positive data, to expand Qutenza's label to include PSNP.

Grunenthal's Qutenza Phase III Trial Completes Enrollment for Post-Surgical Neuropathic Pain

• Grunenthal and Averitas Pharma completed enrollment for the Phase III clinical trial AV001, evaluating Qutenza in post-surgical neuropathic pain (PSNP). • The trial aims to assess the efficacy, safety, and tolerability of Qutenza (capsaicin) 8% topical system for PSNP, a condition affecting over 3 million people in the U.S. annually. • Qutenza is currently approved for postherpetic neuralgia and diabetic peripheral neuropathy; a successful trial could lead to a U.S. label extension in 2026. • The randomized, double-blind trial includes 410 patients, with topline results expected in Q4 2025, potentially offering a non-opioid option for PSNP.

Qutenza Phase III Trial Completes Recruitment for Post-Surgical Neuropathic Pain

• Grünenthal and Averitas Pharma have completed recruitment for the Phase III clinical trial AV001, evaluating Qutenza in post-surgical neuropathic pain (PSNP). • The trial aims to assess the efficacy, safety, and tolerability of Qutenza (capsaicin) 8% topical system in patients with moderate to severe PSNP. • Topline results from the AV001 trial are expected in Q4 2025, with a potential sNDA submission to the FDA for label extension in 2026. • PSNP affects approximately 10% of surgical patients, and Qutenza could provide a non-opioid treatment option for this underserved population.

Grünenthal and Averitas Pharma Complete Phase III Trial Enrollment for Qutenza in Post-Surgical Neuropathic Pain

• Grünenthal and Averitas Pharma completed enrollment for the Phase III AV001 trial evaluating Qutenza (capsaicin 8% topical system) in post-surgical neuropathic pain (PSNP). • The AV001 trial is a randomized, double-blind study involving 410 patients suffering from moderate to severe PSNP for at least six months. • Topline results from the AV001 trial are expected in Q4 2025, with a potential supplemental new drug application (sNDA) submission to the FDA planned for 2026. • Qutenza is currently approved in the U.S. for postherpetic neuralgia and diabetic peripheral neuropathy; this trial aims to expand its label to include PSNP.

Qutenza Phase III Trial Completes Recruitment for Post-Surgical Neuropathic Pain

• Averitas Pharma has completed recruitment for its Phase III clinical trial, AV001, evaluating Qutenza in post-surgical neuropathic pain (PSNP). • The trial aims to assess the efficacy, safety, and tolerability of Qutenza (capsaicin 8% topical system) in 410 patients suffering from moderate to severe PSNP. • Topline results from the AV001 trial are expected in Q4 2025, with a potential supplemental new drug application (sNDA) submission to the FDA in 2026. • If successful, this trial could expand Qutenza's U.S. label to include PSNP, addressing a significant unmet need for non-opioid pain management options.

Grünenthal Completes Enrollment for Phase III Trial of Qutenza in Post-Surgical Neuropathic Pain

• Grünenthal and Averitas Pharma have completed recruitment for the Phase III clinical trial AV001, evaluating Qutenza in post-surgical neuropathic pain (PSNP). • The trial aims to assess the efficacy, safety, and tolerability of Qutenza (capsaicin 8% topical system) in patients suffering from moderate to severe PSNP. • Topline results from the AV001 trial are expected in Q4 2025, with a potential sNDA submission to the FDA for a U.S. label extension in 2026. • PSNP affects approximately 10% of surgical patients, representing a significant unmet need for non-opioid pain management options.

Resiniferatoxin Receives FDA Breakthrough Therapy Designation for Osteoarthritis Pain

• Grünenthal's resiniferatoxin (RTX), a non-opioid therapy, has been granted Breakthrough Therapy Designation by the FDA for knee osteoarthritis pain. • The FDA's decision is based on preliminary clinical evidence suggesting RTX may offer substantial improvement over existing therapies. • Resiniferatoxin is currently in Phase III clinical trials, investigating its efficacy and safety via intra-articular injections for osteoarthritis pain. • Grünenthal's Phase III program will enroll approximately 1,800 patients across 200 sites, with results expected in 2024.
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