PainReform Reports Successful Head-to-Head Comparison of PRF-110 Versus Market Leading Post Surgical Analgesia for Extended Postoperative Pain Relief
2024年1月3日 - 10:30PM
PainReform Ltd. (Nasdaq: PRFX)
("
PainReform" or the "
Company"),
a clinical-stage specialty pharmaceutical company focused on the
reformulation of established therapeutics, today reported in vitro
test results comparing the Company’s lead product, PRF-110, versus
the industry leader, as a topical analgesia for postoperative pain
relief.
The in vitro tests were designed to mimic the
spreadability attribute critically required for post-surgical
topical applications. PRF-110 demonstrated superior formulation
properties with respect to surface-tissue spreading, including a
greater ability to spread evenly due to its viscosity (PRF-110
1,500 cP vs. about 10,000 cP for commercial competitor), and
superior surface interaction with surgical tissue based on a slide
test, which demonstrated sliding of the formulations down inclined,
dry and wet surfaces. In phosphate-buffered saline, the sliding of
PRF-110 was twice that of the competitor.
Ilan Hadar, Chief Executive Officer of
PainReform, stated, “We are encouraged by these results, which
further demonstrate that PRF-110, our long-acting ropivacaine
formulation, provides unique and significant benefits for local
administration in postoperative pain management. PRF-110 clearly
excelled in terms of surface/tissue spreading and staying in
place—a key advantage in achieving effective post-surgical pain
relief—as it is critical to have even distribution inside the
surgical wound. Additionally, PRF-110 is manufactured via a
scalable and cost-effective process, is easy to commercialize, and
contains excipients that are all FDA-approved as GRAS (generally
regarded as safe). As a result, we could not be more encouraged by
the outlook for PRF-110 as we advance the current second part of
our Phase 3 clinical trial.”
Earlier this year, the Company completed the
first part of its Phase 3 clinical trial of PRF-110, in which 15
patients undergoing bunionectomy surgery were enrolled at two
clinical sites in Texas. PRF 110 was well tolerated, all adverse
events were mild, and no serious adverse events were observed,
suggesting a substantial potential advantage to using PRF-110 over
opioids. The second part of the trial, currently underway, is a
double-blind study, randomizing approximately 400 patients at six
clinical sites in the U.S. and measuring pain reduction by PRF-110
over 72 hours compared with placebo.
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.
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Statements
This press release contains forward-looking
statements about our expectations, beliefs and intentions.
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",
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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 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; commercial success and market acceptance
of our product candidates; our ability to establish sales and
marketing capabilities or enter into agreements with third parties
and our reliance on third party distributors and resellers;
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. 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
Ilan HadarChief Executive OfficerPainReform
Ltd.Tel: +972-54-5331725Email: ihadar@painreform.com
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