PainReform Commences Preparations for Pivotal Phase 3 Clinical Trials
HERZLIYA, ISRAEL / ACCESSWIRE / September 29, 2020 / PainReform Ltd. (NASDAQ:PRFX) ("PainReform" or the "Company"), a clinical stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced that following the closing of its initial public offering, it has commenced preparations for the launch of its pivotal Phase 3 clinical trials of PRF-110 for the treatment of post-operative pain. Upon completion of the Phase 3 studies, if successful, the Company plans to apply for a New Drug Approval for the management of post-operative pain.
Based on extensive toxicology and pharmacokinetic studies, as well as positive Phase 2 results, the FDA has granted the Company an IND for PRF-110 and approved the initiation of Phase 3 trials for the treatment of post-operative pain. Unlike many drug trials that take months to years to complete, which are complex and whose endpoints are difficult to interpret, the planned trials are expected to last for a brief number of days with a one-month follow-up, with primary endpoints based on measurement on the familiar scale of 1 (no pain) to 10 (worst imaginable pain).
PRF-110 is a viscous, waterless, clear oil-based solution that is instilled (deposited) directly into the surgical wound to provide localized and extended post-operative analgesia. Its physical characteristics and composition are key to it being well-tolerated. The solution allows for ease of administration by the surgeon.
Key attributes of PRF-100 include:
- PRF-110 is highly viscous and thus stays in place when administered into a surgical wound bed covering the inner surface of the surgical wound.
- PRF-110 remains within the surgical site when the wound is closed, without toxicity or proinflammatory effects.
- PRF-110 is easy to administer and its use is consistent with current surgical practice.
- PRF-110, being a solution, is highly uniform, resulting in consistent and sustained/extended release of the analgesic.
- Ropivacaine, the active drug used in PRF-110, is a safe and well-characterized local anesthetic.
- The components that make up the remainder of the PRF-110 formulation are classified as GRAS (Generally Regarded As Safe) by the FDA.
Dr. Ehud Geller, the Chairman of the Board of the Company commented, "Following the successful completion of our initial public offering for gross proceeds of $20 million, we have commenced preparations for the initiation of our pivotal Phase 3 clinical trials. The current market in post-operative pain treatment is approximately $12 billion, which is expected to grow to over $45 billion by the end of 2026 (Persistence Market Research, 2018). PRF-110 was created to prolong analgesia at the surgical site, thus facilitating early post-operative ambulation, speeding recovery and reducing time in hospital. We are extremely excited to take the next step on this journey to provide relief to patients for post-operative pain and hopefully contribute to the reduction in the frequency of opiate use, thereby lessening the risk of opiate abuse disorder."
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 post-operative 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 post-operative 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.
Notice Regarding Forward-Looking Statements
This press release contains certain forward-looking statements, including statements with regard to PainReform's proposed clinical trials. Words such as "expects," "anticipates" and "intends" or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the clinical trials discussed above will be successfully completed. Completion of the proposed clinical trials are subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, failure of the clinical trials, and the risk factors and other matters set forth in the Company's recent prospectus included in the registration statement, in the form last filed with the SEC. PainReform undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.
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SOURCE: PainReform Ltd.
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