PainReform Provides Regulatory Update on Second Part of its Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery
07 Junho 2023 - 5:30PM
PainReform Ltd. (Nasdaq: PRFX) ("
PainReform" or
the "Company"), a clinical-stage specialty pharmaceutical company
focused on the reformulation of established therapeutics, today
provided a regulatory update on the second part of its Phase 3
clinical trial of PRF-110 in patients undergoing bunionectomy
surgery. The Company’s supplier of the API (active pharmaceutical
ingredient) has received a deficiency notice from the FDA related
to its Drug Master File (DMF). The DMF is the file on record with
the FDA representing the manufacturing process and facility for the
production of the API. As a result, the second part of the Phase 3
trial is expected to commence once the required information has
been provided by the supplier to the FDA and the deficiency notice
has been resolved. None of the issues raised relate to the
Company’s PRF-110 product.
Ilan Hadar, Chief Executive Officer of
PainReform, stated, “Although we encountered what will likely be a
delay in starting the second part of the Phase 3 trial, we are
working closely with our API supplier to ensure the matter is
resolved in the most expedient manner possible. These circumstances
were out of our control, but we believe our supplier is taking the
necessary steps, which should enable us to commence the second part
of the trial in as short a timeframe as possible. We look forward
to providing near-term updates about the timeline as soon as
practicable.”
“We do not believe that the deficiency noted has
or would have any risk to patients. Moreover, it is important to
note that Ropivacaine, the active drug used in PRF-110, has been
shown to be a safe, well-tolerated, and well-characterized local
anesthetic for many years. We are therefore confident of the safety
and quality of our product and the outlook for this program. We
believe PRF-110 holds tremendous promise and will ultimately
contribute to a reduction in the frequency of opiate use following
surgical procedures, thereby lessening the risk of opiate abuse
disorder and ultimately saving lives.”
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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historical matters. These forward-looking statements are based on
assumptions and assessments made in light of management's
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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 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; the impact of the
COVID-19 pandemic on our operations; 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. 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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