A Two-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics and Preliminary Efficacy Study of CA-008 in Patients Undergoing Total Knee Arthroplasy

In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of the study, where CA-008 was compared to placebo. Patients had serial assessments of safety, PK, and drug effect.

Start Date04 Dec 2019

Sponsor / Collaborator

Concentric Analgesics, Inc.Startup

NCT03885596 / CompletedPhase 2

An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy

A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.

Start Date25 Mar 2019

Sponsor / Collaborator

Concentric Analgesics, Inc.Startup

NCT03731364 / CompletedPhase 2

A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 (Vocacapsaicin) in Subjects Undergoing Total Knee Arthroplasty

This is a two-part, Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 (vocacapsaicin) vs. placebo injected/instilled during an elective TKA.

Start Date29 Oct 2018

Sponsor / Collaborator

Concentric Analgesics, Inc.Startup

100 Clinical Results associated with Vocacapsaicin

100 Translational Medicine associated with Vocacapsaicin

100 Patents (Medical) associated with Vocacapsaicin

Literatures (Medical) associated with Vocacapsaicin

01 Aug 2024·Anesthesiology

Safety and Efficacy of Vocacapsaicin for Management of Postsurgical Pain: A Randomized Clinical Trial

Article

Author: Singla, Neil ; Shafer, Steven L ; Leiman, David ; Gottlieb, Ira J ; Teichman, Sam L ; Vaughn, Benjamin ; Minkowitz, Harold S ; Donovan, John F

Background:

Nonopioid management of postsurgical pain remains a major unmet need. Few studies have evaluated transient receptor potential vanilloid subfamily member 1 agonists for analgesia after surgery. This study examines intraoperative vocacapsaicin, a novel prodrug of the transient receptor potential vanilloid subfamily member 1 agonist capsaicin, in a validated model of postsurgical pain.

Methods:

This was a triple-blinded, randomized, placebo-controlled, dose-ranging trial in patients undergoing bunionectomy. Patients were randomized 1:1:1:1 to surgical site administration of 14 ml of placebo or one of three vocacapsaicin concentrations: 0.30, 0.15, or 0.05 mg/ml. The prespecified primary endpoint was the area-under-the-curve of the numerical rating scale pain score at rest through 96 h for the 0.30 mg/ml group. Prespecified ordered, secondary endpoints for the 0.30 mg/ml group included the percentage of patients who did not require opioids from 0 to 96 h, total opioid consumption through 96 h, and the area-under-the-curve of the numerical rating scale pain score for the first week.

Results:

The 147 patients were randomized. During the first 96 h, vocacapsaicin (0.30 mg/ml) reduced pain at rest by 33% versus placebo (primary endpoint, 95% CI [10%, 52%], effect size [Cohen’s d] = 0.61, P = 0.005). Of patients receiving vocacapsaicin (0.30 mg/ml), 26% did not require postoperative opioids for analgesia (P = 0.025) versus 5% of patients receiving placebo. Vocacapsaicin (0.30 mg/ml) reduced opioid consumption over the first 96 h by 50% versus placebo (95% CI [26%, 67%], effect size = 0.76, P = 0.002). Vocacapsaicin (0.30 mg/ml) reduced pain over the first week by 37% versus placebo (95% CI [12%, 57%], effect size = 0.62, P = 0.004). The treatment effect persisted for at least 2 weeks. All study endpoints showed an administered concentration-versus-response relationship. Vocacapsaicin was well tolerated with no differences between groups in any safety parameter.

Conclusions:

A single, local administration of vocacapsaicin during surgery reduced pain and opioid consumption for at least 96 h after surgery compared to control.

Editor’s Perspective:

What We Already Know about This Topic:

What This Article Tells Us That Is New:

01 Oct 2022·Journal of orthopaedic research : official publication of the Orthopaedic Research SocietyQ3 · MEDICINE

Pharmacokinetics and local tissue response to local instillation of vocacapsaicin, a novel capsaicin prodrug, in rat and rabbit osteotomy models

Q3 · MEDICINE

Article

Author: Mease, Kirsten ; Kramer, Susan ; Donovan, John ; Sangameswaran, Lakshmi ; Felx, Melanie ; Knotts, Tarra

Abstract:

Vocacapsaicin is a novel prodrug of trans‐capsaicin (trans‐8‐methyl‐N‐vanillyl‐6‐nonenamide) being developed as a nonopioid, long‐lasting, site‐specific treatment for postsurgical pain management. The objective of these studies was to examine the safety and tolerability of vocacapsaicin in an osteotomy model in two animal species and to evaluate bone healing parameters. Rats undergoing unilateral femoral osteotomy received a single perioperative administration (by instillation) of vocacapsaicin (vehicle, 0.15, 0.3, and 0.6 mg/kg). Rabbits undergoing unilateral ulnar osteotomy received a single perioperative administration (by infiltration and instillation) of vocacapsaicin (vehicle, 0.256 and 0.52 mg) alone or in combination with 0.5% ropivacaine. Clinical signs, body weights, food consumption, radiography, histopathologic examinations, ex vivo bone mineral density measurements (rats only), and biomechanical testing were evaluated at 4 and 8 weeks in rats and at 2 and 10 weeks in rabbits. Plasma samples were also collected in rabbits. There were no vocacapsaicin‐related effects on mortality, clinical observations, body weight, or food consumption in either species. Systemic exposure to vocacapsaicin and its metabolites, including capsaicin, was transient. In rats, vocacapsaicin was devoid of deleterious effects on bone healing parameters, and there was a trend for enhanced bone healing in rats treated with the mid‐dose. In rabbits, vocacapsaicin administered alone or in combination with ropivacaine did not adversely affect bone healing parameters. In conclusion, a single perioperative administration of vocacapsaicin in unilateral osteotomy models was well tolerated, locally and systemically, supporting its continued development as a novel, nonopioid treatment for postsurgical pain management.

01 Nov 2014·Annals of oncology : official journal of the European Society for Medical OncologyQ1 · MEDICINE

Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies

Q1 · MEDICINE

Article

Author: Harmankaya, K ; Maio, M ; Hamid, O ; Konto, C ; O'Day, S J ; Wolchok, J D ; Cykowski, L ; Weber, J S ; McHenry, M B ; Neyns, B ; Lebbé, C

BACKGROUND:

This report provides a survival update at a follow-up of >5 years (5.5-6 years) for patients with advanced melanoma who previously received ipilimumab in phase II clinical trials. Safety and efficacy data following ipilimumab retreatment are also reported.

PATIENTS AND METHODS:

Patients who previously received ipilimumab 0.3, 3, or 10 mg/kg in one of six phase II trials (CA184-004, CA184-007, CA184-008, CA184-022, MDX010-08, and MDX010-15) were eligible to enroll in the companion study, CA184-025. Upon enrollment, patients initially received ipilimumab retreatment, extended maintenance therapy, or were followed for survival only. Overall survival (OS) rates were evaluated in patients from studies CA184-004, CA184-007, CA184-008, and CA184-022. Safety and best overall response during ipilimumab retreatment at 10 mg/kg were assessed in study CA184-025.

RESULTS:

Five-year OS rates for previously treated patients who received ipilimumab induction at 0.3, 3, or 10 mg/kg were 12.3%, 12.3%-16.5%, and 15.5%-28.4%, respectively. Five-year OS rates for treatment-naive patients who received ipilimumab induction at 3 or 10 mg/kg were 26.8% and 21.4%-49.5%, respectively. Little to no change in OS was observed from year 5 up to year 6. The objective response rate among retreated patients was 23%. Grade 3/4 immune-related adverse events occurred in 25%, 5.9%, and 13.2% of retreated patients who initially received ipilimumab 0.3, 3, and 10 mg/kg, with the most common being observed in the skin (4.2%, 2.9%, 3.8%) and gastrointestinal tract (12.5%, 2.9%, 3.8%), respectively.

CONCLUSIONS:

At a follow-up of 5-6 years, ipilimumab continues to demonstrate durable, long-term survival in a proportion of patients with advanced melanoma. In some patients, ipilimumab retreatment can re-establish disease control with a safety profile that is comparable with that observed during ipilimumab induction. Further studies are needed to determine the contribution of ipilimumab retreatment to OS.

CLINICALTRIALSGOV:

NCT00162123.

News (Medical) associated with Vocacapsaicin

06 Aug 2024

·www.businesswire.com

Concentric Analgesics Announces Data Highlighting Two Weeks of Durable Pain Relief and Earlier Cessation of Opioids in Two Surgical Procedures

AMSTERDAM--( BUSINESS WIRE )--Concentric Analgesics, Inc., a clinical-stage biopharmaceutical company developing novel, non-opioid pain therapeutics, today announced a poster presentation of additional favorable clinical data for vocacapsaicin, its first-in-class lead product candidate for the management of postsurgical pain, at the 2024 International Association for the Study of Pain (IASP) World Congress being held August 5- 9, 2024 in Amsterdam, Netherlands. The presentation “TRPV1 from Bench to Bedside: Vocacapsaicin Produces Durable Postsurgical Analgesia and Earlier Opioid Cessation” includes data from previously announced results of vocacapsaicin in Phase 2 trials for patients undergoing total knee arthroplasty (TKA) and bunionectomy. Both studies were multi-center, randomized, controlled clinical trials measuring postsurgical analgesia and opioid consumption following a single intra-operative administration of vocacapsaicin. Vocacapsaicin is an innovative, water-soluble prodrug of capsaicin. Vocacapsaicin rapidly releases capsaicin at the surgical site after a single local administration during surgery which triggers activation of the TRPV1 receptor on pain-specific nerves. TRPV1 activation is known to produce analgesia that lasts for weeks to months without causing sensory numbness or motor weakness. This is a highly differentiated mechanism of action from local anesthetics, such as bupivacaine including extended-release formulations, which are shorter-acting and produce sensory numbness and motor weakness. In the poster, separate trials in bunionectomy and total knee arthroplasty are presented showing durable analgesia that lasted for two weeks with reduced opioid usage and earlier opioid cessation following both surgeries. The data from the bunionectomy trial were recently published in the August issue of the journal ANESTHESIOLOGY, while this is the first presentation of the data on opioid cessation from the TKA trial. Following bunionectomy, all patients receiving an effective dose of vocacapsaicin were able to stop opioid analgesic medication by 5 days compared to 16% in the placebo group who still required opioids, half of which were still using opioids at the end of the two-week study. The differences were statistically significant. At two weeks following total knee arthroplasty, 50% more patients in the placebo group still required opioid analgesia compared to the vocacapsaicin group (58% vs 38%, respectively). The difference was also statistically significant. The risk of persistent opioid use, a known risk factor for opioid dependence and abuse, increases most sharply in patients who continue taking opioids after five days. The United States Congress recently passed the Non-Opioids Prevent Addiction in the Nation (NO PAIN) Act, set to go into effect January 2025, which will increase patient and provider access to non-opioid pain management options by removing the barriers associated with reimbursement for the Medicare population. Harold Minkowitz, M.D., President of Analgesics, Perioperative & Hospital Based Research at the HD Research LLC, an Evolution Research Group portfolio company and an investigator in both studies stated, “Vocacapsaicin is unlike anything on the market today, given its unique mechanism of action enabling long-lasting postsurgical analgesia. This distinct property allows for earlier cessation of opioids, an effect that has not been seen before with a single drug administration. If approved, vocacapsaicin will revolutionize post-operative pain management.” “The results of both studies are impressive,” said Edwin Su, M.D., Attending Orthopedic Surgeon, Hospital for Special Surgery and Professor of Orthopedic Surgery, Weill Cornell Medical College. “The TKA data is particularly important given that pain after joint replacement can last for weeks. The reduction in opioid consumption over two weeks was accompanied by earlier ambulation that will likely translate into earlier discharge, faster recovery and fewer callbacks. Vocacapsaicin has the potential to be an important addition to care pathways and meaningfully improve patient recovery after joint replacement.” John Donovan, M.D., Founder and Chief Scientific Officer at Concentric Analgesics, noted, “In 2018, vocacapsaicin received Breakthrough Therapy Designation from the FDA for its effect on reducing opioid usage. The data from these two trials covering a variety of clinically meaningful opioid endpoints extend our understanding about the impact of vocacapsaicin on opioid reliance after surgery and have us well-positioned for Phase 3 trials and bringing a much needed innovative therapeutic to patients.” Presentation details are below: Title: TRPV1 from Bench to Bedside: Vocacapsaicin Produces Durable Postsurgical Analgesia and Earlier Opioid Cessation Date and time: August 6, 2024 at 3:15 PM (local time) Poster number: TU509 Lead author: Sam Teichman, M.D., Head of Clinical Development, Concentric Analgesics Presenter: Ben Vaughn, M.S., RAC, Chief Strategist Biostatistics and Protocol Design at Rho The poster is available on the meeting website: https://posters.worldcongress2024.org/poster/trpv1-bench-to-bedside-vocacapsaicin-causes-durable-postsurgical-analgesia-earlier-opioid-cessation/ Data from the bunionectomy trial appears in the August issue of the journal ANESTHESIOLOGY , Opioid Use and Abuse After Painful Surgery Effective management of pain after surgery remains an unmet medical need. More than 30 million surgeries are performed in the U.S. annually that require prescription drugs for pain management. Oral opioid analgesics remain an integral part of postsurgical pain management despite common side effects, safety concerns, and the risk of persistent opioid use which can lead to abuse and beyond. According to the Centers for Disease Control and Prevention, more than 80,000 Americans died from opioid overdoses in 2022 – more than the annual total number of deaths from automobile accidents and gun deaths combined. About Vocacapsaicin (formerly CA-008) Concentric Analgesics’ lead product candidate for postsurgical pain is a first-in-class prodrug therapeutic that rapidly converts to capsaicin, a potent and well-studied TRPV1 agonist. Unlike local anesthetics, capsaicin selectively desensitizes pain-conducting nerve fibers. Vocacapsaicin has the potential to reduce or even eliminate the need for opioids in the postsurgical recovery period and provide clinically meaningful pain relief for two weeks. Vocacapsaicin has received both Fast Track Designation and Breakthrough Therapy Designation from the US Food and Drug Administration. About Concentric Analgesics Concentric Analgesics is a clinical-stage, biopharmaceutical company focused on developing and commercializing novel, non-opioid pain therapeutics. The company’s portfolio of proprietary products is designed to provide long-lasting, selective pain relief after a single local administration. The company is planning Phase 3 studies for vocacapsaicin, its lead product candidate for postsurgical pain. Concentric has two additional programs for osteoarthritis pain and chronic refractory pain. For more information, please visit: www.concentricanalgesics.com .

Phase 2Phase 3Fast TrackBreakthrough TherapyClinical Result

06 Aug 2024

·www.pharmaceutical-technology.com

Concentric Analgesics highlights data on vocacapsaicin for pain relief

Data on vocacapsaicin suggest significant post-surgery pain relief, preventative of opioid dependency. Image: Shutterstock / FGC. California-based biopharmaceutical company Concentric Analgesics announced they will present data today (6 August) on their novel pain management drug vocacapsaicin, highlighting pain relief and early opioid cessation. The poster presentation, to be given at the International Association for the Study of Pain (IASP) World Congress in Amsterdam, NL, includes new Phase II data on opioid cessation with vocacapsaicin following total knee arthroplasty (TKA) (NCT03731364). The trial found that two weeks following TKA, 38% of patients receiving the drug required opioid-based analgesia compared to 58% of patients in the placebo group. CEO Frank Bellizzi told Pharmaceutical Technology that Concentric has a further, “four clinical studies” planned for vocacapsaicin, and that, “the first three studies have been cleared by the FDA.” He added that Concentric is “currently seeking to forge commercial partnerships.” Also included in today’s presentation will be data from a Phase II trial investigating vocacapsaicin following bunionectomy (NCT03599089). These data, published in Anesthesiology , demonstrated that vocacapsaicin enabled opioid use cessation by 5 days post-surgery for all patients; this was achieved by only 16% of patients receiving placebo, half of whom continued opioid use at two weeks. This data is significant given the US’s opioid epidemic. The risk of persistent opioid use which can lead to addiction increases most significantly once use continues past 5 days. “The reduction in opioid consumption over two weeks was accompanied by earlier ambulation that will likely translate into earlier discharge, faster recovery and fewer callbacks”, according to Edwin Su, MD, from Weill Cornell Medical College. See Also: Eli Lilly boosts sales forecast by $3bn as diabetes and weight loss drugs propel revenue Recursion and Exscientia merge to form drug discovery company Vocacapsaicin is a prodrug of capsaicin which releases its product locally. It triggers TRPV1 receptors on pain-specific nerves to induce long-lasting analgesia. Vocacapsaicin’s effects can last months without numbness or motor weakness. Harold Minkowitz, MD, from HD Research, notes “Vocacapsaicin is unlike anything on the market today, given its unique mechanism of action enabling long-lasting postsurgical analgesia.” Vocacapsaicin received Fast Track designation from the US Food and Drug Administration (FDA) in 2017 and Breakthrough Therapy designation in 2018. In 2019, Concentric raised $76mn in Series B financing, and has raised $40mn in the past three years, as per GlobalData. GlobalData is the parent company of Pharmaceutical Technology . The drug could benefit from the Non-Opioids Prevent Addition in the Nations (NO PAIN) Act passed by the US congress and set to go into effect in January 2025. This would increase access to non-opioid pain management by removing reimbursement barriers for Medicare.

Phase 2Fast TrackClinical ResultBreakthrough Therapy

24 Jul 2024

·www.businesswire.com

Concentric Analgesics Announces Peer-Reviewed Publication of Positive Phase 2 Clinical Data in ANESTHESIOLOGY

SAN FRANCISCO--( BUSINESS WIRE )--Concentric Analgesics, Inc., a clinical-stage biopharmaceutical company developing novel, non-opioid pain therapeutics, today announced publication of a multicenter, randomized clinical trial evaluating vocacapsaicin on the cover of the August 2024 issue of ANESTHESIOLOGY, the highest impact journal in the specialty. Results showed that a single dose of vocacapsaicin significantly reduced pain and opioid use for at least one week after bunionectomy, the most commonly studied model to assess and validate analgesic benefit for postsurgical pain. Vocacapsaicin is an innovative, water-soluble prodrug of capsaicin. Vocacapsaicin rapidly releases capsaicin at the surgical site after a single local administration during surgery which triggers activation of the TRPV1 receptor on pain-specific nerves. TRPV1 activation is known to produce analgesia that lasts for weeks to months without causing sensory numbness or motor weakness. This is a highly differentiated mechanism of action from local anesthetics, such as bupivacaine, which are short-acting and produce sensory numbness and motor weakness. In the Phase 2 study, 147 patients were randomized to receive one of three doses of intraoperative locally administered vocacapsaicin (0.30, 0.15 or 0.05 mg/ml) or placebo. All patients received identical perioperative analgesia. The prospective objective was to test the therapeutic benefit of the 0.30 mg/ml dose. Results of prespecified primary and key secondary endpoints for the 0.30 mg/ml group, compared to placebo control group, showed: 33% reduction in pain at rest during 0–Day 5 (p=0.005) 37% reduction in pain at rest during 0–Day 8 (p=0.004) 50% reduction in opioid consumption during 0-Day 5 (p=0.002) Five times as many patients receiving vocacapsaicin never needed any postoperative opioid analgesia compared to control (26% vs 5%, respectively, p=0.025). In addition, 100% of the vocacapsaicin group stopped opioids by Day 5 while 16% of the control group still required opioid analgesia at that time (p=0.001) 8% in control group continued to need opioids at Day 15 The analgesic effect of vocacapsaicin was persistent and consistently evident on each day throughout the two weeks following surgery A clear dose response was documented Vocacapsaicin appeared safe and well tolerated with no differences between groups in any safety parameter. The risk of persistent opioid use, a known risk factor for opioid dependence and abuse, increases most sharply in the initial days of treatment, particularly for patients who continue taking opioids after 5 days. Lead author, Steven L. Shafer, MD, Professor Emeritus, Stanford University School of Medicine and adviser to Concentric, said, “This is the first demonstration of a single intra-operative injection leading to earlier cessation of opioids after surgery. By targeting TRPV1 receptors, vocacapsaicin eclipses the duration of pain relief possible from local anesthetic formulations.” In his accompanying editorial, A Spicy New Treatment for Postoperative Pain , David Clark, MD, PhD, Professor of Anesthesiology, Perioperative and Pain Medicine, Stanford University, stated, "Fundamental advancements in our field do not occur every day, so it is particularly exciting when early reports of innovative new treatments are published. The potential value of this type of treatment is enormous.” Eske K. Aasvang, MD, Professor of Anaesthesiology, Rigshospitalet Copenhagen and Chairman of the Danish Medicines Board’s National Guideline on Follow-up After Opioid Prescription, stated, “The most important finding in the vocacapsaicin studies by Concentric Analgesics is the reduced opioid consumption and, of particular significance, the earlier cessation. This drug gives us hope for fewer long-term opioid users and less of the all too frequent opioid-related severe adverse events including abuse and death." Michael D. Maloney, MD, Dean’s Professor of Orthopaedics, Chief of the Division of Sports Medicine, and Medical Director of the Ambulatory Surgery Center at University of Rochester Medical Center, said, “In addition to these data, I have been equally impressed by the Phase 2 data on the use of vocacapsaicin during total knee arthroplasty published in abstracts. Orthopedic surgeons want an easy-to-use, intra-operative non-opioid analgesic that can reduce pain during the full postsurgical recovery period, including rehabilitation.” “We are pleased that our Phase 2 study merited the cover of ANESTHESIOLOGY, along with the accompanying editorial, which we believe validates vocacapsaicin’s extraordinary potential clinical impact,” said Frank Bellizzi, chief executive officer of Concentric Analgesics. “Our plans to begin Phase 3 studies are largely completed and we remain deeply committed to bringing this innovative new treatment to patients and clinicians as quickly as possible.” The paper, editorial and supplemental infographics are available online: https://pubs.asahq.org/anesthesiology/article/141/2/250/140092/Safety-and-Efficacy-of-Vocacapsaicin-for Opioid Use and Abuse After Painful Surgery Effective management of pain after surgery remains an unmet medical need. More than 30 million surgeries are performed in the U.S. annually that require prescription drugs for pain management. Oral opioid analgesics remain an integral part of postsurgical pain management despite common side effects, safety concerns, and the risk of persistent opioid use which can lead to abuse and beyond. According to the Centers for Disease Control and Prevention, more than 80,000 Americans died from opioid overdoses in 2022 – more than the annual total number of deaths from automobile accidents and gun deaths combined. About Vocacapsaicin (formerly CA-008) Concentric Analgesics’ lead product candidate for postsurgical pain is a first-in-class prodrug therapeutic that rapidly converts to capsaicin, a potent and well-studied TRPV1 agonist. Unlike local anesthetics, capsaicin selectively desensitizes pain-conducting nerve fibers. Vocacapsaicin has the potential to reduce or even eliminate the need for opioids in the postsurgical recovery period and provide clinically meaningful pain relief for two weeks. Vocacapsaicin has received both Fast Track Designation and Breakthrough Therapy Designation from the US Food and Drug Administration. About Concentric Analgesics Concentric Analgesics is a clinical-stage biopharmaceutical company focused on developing and commercializing novel, non-opioid pain therapeutics. The company’s portfolio of proprietary products is designed to provide long-lasting, selective pain relief after a single local administration. The company is planning Phase 3 studies for vocacapsaicin, its lead product candidate for postsurgical pain. Concentric has two additional programs for osteoarthritis pain and chronic refractory pain. For more information, please visit: www.concentricanalgesics.com .

Phase 2Phase 3Clinical ResultFast TrackBreakthrough Therapy

100 Deals associated with Vocacapsaicin

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Indication	Highest Phase	Country/Location	Organization	Date
Hernia, Ventral	Phase 2	US	Concentric Analgesics, Inc.Startup	09 Sep 2020
Pain	Phase 2	US	Concentric Analgesics, Inc.Startup	25 Mar 2019
Pain, Postoperative	Phase 2	US	Concentric Analgesics, Inc.Startup	09 Jul 2018
Hallux Valgus	Phase 1	US	Concentric Analgesics, Inc.Startup	02 Nov 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03731364 (NEWS) Manual	Phase 2	Pain, Postoperative	-	Vocacapsaicin	iuyjmpudfx(hzyagkhecm) = kkihawcncs lpfybmjxmo (kvftjdubwa )	Positive	06 Aug 2024
				Placebo	iuyjmpudfx(hzyagkhecm) = myfteowzxc lpfybmjxmo (kvftjdubwa )
NCT03599089 (BusinessWire) Manual	Phase 2	Pain, Postoperative	147	Vocacapsaicin 0.30 mg/ml	waifyowbav(qugbyspsyl) = exwtzkjpkf imgwhpthkh (aqycowxgvm ) View more	Positive	24 Jul 2024
				Placebo	umuqnbazvj(bwgmkrsebj) = xnuxecifwu gmoadvjnqa (wraiyelvqj )
NCT03731364 (CTgov)	Phase 2	Pain, Postoperative	55	CA-008 (CA-008 5 mg (0.05 mg/mL) Cohort 1)	krvshveccr(flaiirowjv) = tuqehkotax icmocidzcx (wieeyrmdkn, mhnapxlhzw - rsjpucqotp) View more	-	15 Feb 2022
				Placebo (Placebo - Cohort 1)	krvshveccr(flaiirowjv) = uhcuievjiq icmocidzcx (wieeyrmdkn, dkmyjleczm - kqxdaaddre) View more
NCT04203537 (CTgov)	Phase 1/2	Pain, Postoperative	193	Placebo (Placebo)	gureutwhee(nduqryfctm) = iuqmbkvxha ujykerlnxs (gactpplqsi, okltvobruh - wdjsfjrvjm) View more	-	12 Jan 2022
				CA-008 (CA-008 36 mg)	yyvhhyeosh(aemjychyoh) = yzhgzfzxxf dwaatngevu (ddjsbpkusa, hsxuwmbswa - pihbnnpolt) View more
NCT03885596 (CTgov)	Phase 2	Pain	36	Acetaminophen Oral+Ketorolac+Fentanyl+Lidocaine HCl+CA-008+Bupivacaine Hydrochloride+Celecoxib (CA-008 Cohort 1)	pxquwthfwt(vbcmmktqxw) = eapgbbqxee xlnpvmsfkn (rqwbnjnwtq, eojnysbyih - tmgcuoaypb) View more	-	27 Oct 2021
				Acetaminophen Oral+Lidocaine Hydrochloride+Ketorolac+Fentanyl+CA-008+Bupivacaine Hydrochloride+Celecoxib (CA-008 Cohort 2)	pxquwthfwt(vbcmmktqxw) = opgfebjvqc xlnpvmsfkn (rqwbnjnwtq, qojbwupirc - akuemlvvtr) View more
NCT03599089 (CTgov)	Phase 2	Pain, Postoperative	147	Placebo+Acetaminophen+Ketorolac+Bupivacaine Hydrochloride+Oxycodone	hsewqwkftl(akuentydtn) = sxzfvkqjcf kqczoeyhoa (khwujfxtru, znqctkvipr - nqmnwdfxix) View more	-	11 Aug 2021
NCT03599089 (Corporate Publications) Manual	Phase 2	-	147	Standard of Care+CA-008	rqllsuavgp(nshebyhrrr) = wkjczsrchh lyepctdoez (zgfiuvgtlm ) View more	Positive	08 Nov 2018
				Standard of Care	jpzkepvzsf(gxapxqhrjt) = tmeanaespt nvtsfqmsct (pkxrrrcfhs )
NCT03307837 (Corporate Publications) Manual	Phase 1	Pain, Postoperative	40	vocacapsaicin	ckwtcwasrf(uzxlzpbmtc) = lknhydeumv wtsqxocosd (dgcesnnkve ) View more	Positive	14 May 2018

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