HOPE Therapeutics, Inc. and NRx Pharmaceuticals, Inc. (Nasdaq:NRXP) Announce Alignment with FDA on Pediatric Study Plan for NRX-100 (ketamine)
Rhea-AI Summary
NRx Pharmaceuticals (Nasdaq: NRXP) has announced alignment with the FDA on the initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in treating suicidal depression. This alignment is important for the upcoming New Drug Application (NDA) filing, scheduled for Q4 2024. Key points include:
1. FDA recognizes the importance of addressing suicidal depression in adolescents aged 9-17.
2. NRx commits to conducting a clinical trial for NRX-100 in this age group post-adult approval.
3. The company remains on track for NDA filing in Q4 2024, with an anticipated PDUFA date in Q2 2025.
4. Additional neurotoxicity studies in juvenile animals will support safety assessments.
The FDA's feedback highlights the growing crisis of youth suicide in the US, with 10% of high school students attempting suicide in the past year.
Positive
- Alignment with FDA on Pediatric Study Plan for NRX-100, a important step for NDA filing
- On track for NDA filing in Q4 2024 with anticipated PDUFA date in Q2 2025
- Potential to address a significant unmet medical need in adolescent suicidal depression
- FDA recognition of the urgent need for treatment in the 9-17 age group
Negative
- Additional clinical trials required for adolescents aged 9-17, potentially increasing costs and time to market for this demographic
- Need for additional neurotoxicity studies in juvenile animals, which may delay or impact approval for pediatric use
News Market Reaction
On the day this news was published, NRXP declined 2.07%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
- FDA response highlights the importance of addressing suicidal depression in adolescents age 9-17
- Alignment on initial Pediatric Study Plan (iPSP) is a gating requirement for the upcoming filing of an NRX-100 New Drug Application (NDA) for suicidal depression
- NRx remains on track to file the NDA for NRX-100 in Q4 2024 with anticipated PDUFA date in Q2 2025
Suicide is a growing crisis among adolescents in
In support of its upcoming NDA filing, NRx will be submitting existing data supporting the safety and efficacy of ketamine to treat suicidal depression in adults. FDA has now documented its recognition that suicide is a serious and growing public health concern in adolescents as well. Based on the guidance received, NRx and HOPE Therapeutics will commit to conducting a clinical trial of NRX-100 in adolescents aged 9-17 with suicidal depression, but will not be required to study the effects of NRX-100 in younger age groups, following initial approval of NRX-100 in adults. Additional neurotoxicity studies will be conducted in juvenile animal subjects to support the safety of intravenous ketamine in this younger population.
"Youth suicide has reached crisis proportions in
About NRx Pharmaceuticals, Inc.
NRx Pharmaceuticals is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain, and PTSD. The Company is developing NRX-101, an FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. NRx plans to file an NDA for Accelerated Approval for NRX-101 in patients with bipolar depression and suicidality or akathisia. NRX-101 additionally has potential to act as a non-opioid treatment for chronic pain, as well as a treatment for complicated UTI.
NRx has recently announced plans to submit a New Drug Application for NRX-100 (IV ketamine) for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement. NRx was awarded Fast Track Designation for development of ketamine (NRX-100) by the US FDA as part of a protocol to treat patients with acute suicidality.
About HOPE Therapeutics, Inc.
HOPE Therapeutics, Inc. (www.hopetherapeutics.com) is a care delivery company developing a best-in-class network of clinics that currently offer ketamine and other lifesaving therapies to patients with suicidal depression and related disorders, together with a digital therapeutic-enabled platform designed to augment and preserve the clinical benefit of NMDA-targeted drug therapy.
Notice Regarding Forward-Looking Statements
The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, among others, statements regarding the proposed public offering and the timing and the use of the proceeds from the offering. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy and liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise.
1 https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/Pediatric-Study-Plans--Content-of-and-Process-for-Submitting-Initial-Pediatric-Study-Plans-and-Amended-Pediatric-Study-Plans.pdf
2 https://www.cdc.gov/healthyyouth/data/yrbs/pdf/YRBS_Data-Summary-Trends_Report2023_508.pdf
3 https://www.apa.org/monitor/2023/07/psychologists-preventing-teen-suicide
View original content to download multimedia:https://www.prnewswire.com/news-releases/hope-therapeutics-inc-and-nrx-pharmaceuticals-inc-nasdaqnrxp-announce-alignment-with-fda-on-pediatric-study-plan-for-nrx-100-ketamine-302208338.html
SOURCE NRx Pharmaceuticals, Inc.
FAQ
What is the status of NRX-100 (ketamine) development for suicidal depression by NRx Pharmaceuticals (NRXP)?
What age group will NRx Pharmaceuticals (NRXP) target for NRX-100 in pediatric suicidal depression studies?
When is NRx Pharmaceuticals (NRXP) expected to file the NDA for NRX-100?
What is the significance of the FDA's feedback on NRX-100 for NRx Pharmaceuticals (NRXP)?
