PainReform Announces Development and Successful Manufacturing of New Formulations Providing Anti-Inflammatory and Extended Analgesic Effects
August 12 2024 - 8:00AM
PainReform Ltd. (Nasdaq: PRFX) ("
PainReform" or
the "
Company"), a clinical-stage specialty
pharmaceutical company focused on the reformulation of established
therapeutics, announces the successful development and
manufacturing of new patented formulations of its extended
postoperative pain relief therapy, PRF-110. These novel
formulations may incorporate both the analgesic and an
anti-inflammatory agent, designed to enhance postoperative
recovery.
Nerve blockades are critical for managing pain
over extended periods, preventing complications, and accelerating
recovery post-surgery. Adding an anti-inflammatory agent, such as a
steroid, to a local anesthetic like ropivacaine has been
demonstrated to extend and enhance the anesthetic effect. This
combination not only provides a quicker onset of pain relief but
also reduces the reliance on opioids post-operatively.
Ropivacaine is preferred over bupivacaine for
surgical blocks due to its lower neurotoxicity and cardiotoxicity,
as well as a reduced risk of bone chondrotoxicity. By combining
ropivacaine with dexamethasone, a potent anti-inflammatory agent,
PainReform aims to deliver superior pain management. This
combination is already employed in various peripheral nerve blocks,
including transversus abdominis plane blocks, interscalene blocks,
and adductor canal blocks.
PainReform's PRF-110 formulation uniquely
supports the administration of ropivacaine-steroid mixtures while
ensuring product stability—a challenging feat with such
combinations. The company holds a patent for the ropivacaine and
dexamethasone mixture and has successfully manufactured specific
combination products of PRF-110, containing 3.6% or 3.0%
ropivacaine and 0.1-0.5% dexamethasone. These formulations have
demonstrated promising stability in ongoing studies.
"Long-acting mixtures of local anesthetics and
anti-inflammatory agents are extensively used in nerve blocks,
orthopedics, and other medical fields to provide symptomatic
relief," said Ehud Geller, Chairman and interim Chief Executive
Officer of PainReform. "The unique properties of PRF-110, including
its long-acting nature, viscosity, and safety, position it well for
combination with anti-inflammatory agents to further enhance
outcomes in postoperative pain management and recovery."
PainReform remains committed to advancing its
pipeline of innovative pain management therapies to improve patient
outcomes and quality of life. The company will continue to update
stakeholders on the progress of its clinical studies and product
development.
About PainReform
PainReform is a clinical-stage specialty
pharmaceutical company focused on the reformulation of established
therapeutics. PRF-110, the Company's lead product is based on the
local anesthetic ropivacaine, targeting the postoperative pain
relief market. PRF-110 is an oil-based, viscous, clear solution
that is deposited directly into the surgical wound bed prior to
closure to provide localized and extended postoperative analgesia.
The Company's proprietary extended-release drug-delivery system is
designed to provide an extended period of post-surgical pain relief
without the need for repeated dose administration while reducing
the potential need for the use of opiates. For more information,
please visit www.painreform.com.
Notice Regarding Forward-Looking
Statements
This press release contains forward-looking
statements about our expectations, beliefs and intentions including
with respect to objectives, plans and strategies and expected
timing of results. Forward-looking statements can be identified by
the use of forward-looking words such as "believe", "expect",
"intend", "plan", "may", "should", "could", "might", "seek",
"target", "will", "project", "forecast", "continue" or "anticipate"
or their negatives or variations of these words or other comparable
words or by the fact that these statements do not relate strictly
to historical matters. These forward-looking statements are based
on assumptions and assessments made in light of management's
experience and perception of historical trends, current conditions,
expected future developments and other factors believed to be
appropriate. Forward-looking statements in this press release are
made as of the date of this press release, and we undertake no duty
to update or revise any such statements, whether as a result of new
information, future events or otherwise. Forward-looking statements
are not guarantees of future performance and are subject to risks
and uncertainties, many of which are outside of our control. Many
factors could cause our actual activities or results to differ
materially from the activities and results anticipated in forward-
looking statements, including, but not limited to, the following:
our ability to continue as a going concern, our history of
significant losses, our need to raise additional capital and our
ability to obtain additional capital on acceptable terms, or at
all; our dependence on the success of our initial product
candidate, PRF-110; the outcomes of preclinical studies, clinical
trials and other research regarding PRF-110 and future product
candidates; our limited experience managing clinical trials;
our ability to retain key personnel and recruit additional
employees; our reliance on third parties for the conduct of
clinical trials, product manufacturing and development; the impact
of competition and new technologies; our ability to comply with
regulatory requirements relating to the development and marketing
of our product candidates; our ability to establish and maintain
strategic partnerships and other corporate collaborations; the
implementation of our business model and strategic plans for our
business and product candidates; the scope of protection we are
able to establish and maintain for intellectual property rights and
our ability to operate our business without infringing the
intellectual property rights of others; the overall global economic
environment; our ability to develop an active trading market for
our ordinary shares and whether the market price of our ordinary
shares is volatile; and statements as to the impact of the
political and security situation in Israel on our business,
including due to the current war between Israel and Hamas. More
detailed information about the risks and uncertainties affecting us
is contained under the heading "Risk Factors" included in the
Company's most recent Annual Report on Form 20-F and in other
filings that we have made and may make with the Securities and
Exchange Commission in the future.
Contact:Crescendo
Communications, LLCTel: 212-671-1021Email:
prfx@crescendo-ir.com
Dr. Ehud GellerChairman and interim Chief
Executive OfficerPainReform Ltd.Tel: +972-54-4236711Email:
egeller@medicavp.com
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