Clinical Data from Phase 2 Studies in Total
Knee Arthroplasty (TKA) and Bunionectomy to be Presented at the
2024 International Association for the Study of Pain (IASP) World
Congress
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240805074824/en/
For More Information: Frank Bellizzi Chief Executive
Officer Concentric Analgesics, Inc.
frank@concentricanalgesics.com
Susan Kinkead susan@kinkeadcomm.com 415-509-3610