Pain: The Last Frontier
Next generation of non-opioid analgesia
NEX-127 (RELIVRA™) - OUR FLAGSHIP COMPOUND, OUTPERFORMED EXISTING PAIN PRODUCTS IN MT.SINAI HOSPITAL HUMAN CLINICAL TRIALS
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VAS, mm
100
80
60
40
20
0
.
.
Relivra
Diclofenac
Lidocaine
Benzocaine
Ketoprofen
METHODOLOGY NOTES
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Data from the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), OpenSIGLE and ProQuest Dissertations and Theses, NIH Pubmed, and Relivra limited clinical trials were used for this chart.
Nexa Bioscience is developing a differentiated topical non-opioid analgesic program built around Naringenin-7-O-Hemisuccinate – Lidocaine Mutual NCE Prodrug in a Thermosensitive Gel, designed for post-procedural and wound-related pain. The platform is engineered to deliver localized, rapid-onset relief with extended duration, addressing the clinical gap where existing topical agents frequently fall short. With human clinical validation completed and a defined Phase II bridging pathway, Nexa is positioning this asset as a transaction-ready program aligned with current pharmaceutical demand for credible, de-risked pain solutions.
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Clinically Validated Innovation in Pain
WE HAVE THE SOLUTION
Pain remains one of the largest unresolved categories in modern medicine—especially in the acute post-procedure setting, where patients need fast relief that lasts through the critical recovery window. Yet today’s topical options are largely limited to legacy active ingredients such as menthol, diclofenac, and conventional lidocaine formats, which often fall short on either onset, depth, or duration of analgesia in real-world use.
NEX-127 was developed specifically to address this performance gap. It is a New Chemical Entity (NCE) mutual prodrug—Naringenin-7-O-Hemisuccinate + Lidocaine—formulated in a thermosensitive gel designed to stay localized at the application site and support both rapid and sustained pain control. Supported by real-world clinical use and completed human clinical trials at Mount Sinai Hospital (New York), NEX-127 is being advanced through focused Phase II bridging and regulatory execution to position the asset for near-term strategic licensing or acquisition.
01
THE UNMET NEED
Post-procedure and wound-related pain is one of the most common and expensive pain settings in healthcare—and it is still poorly served with non-opioid options. Patients need relief that starts quickly, holds through the highest-pain window, and stays localized to the affected area. In practice, many patients are discharged with limited effective topical choices and are still pushed toward systemic pain medications when topical options fail to cover the real intensity and duration of recovery pain.
This creates a clear and persistent gap: a topical therapy that can deliver meaningful relief during the acute post-procedure period, without systemic exposure, would be clinically valuable, commercially significant, and highly attractive to strategic buyers focused on non-opioid pain care.
03
THE OPIOID RESET
Pain management is undergoing a structural reset. Health systems, prescribers, and patients are actively reducing opioid reliance, especially after outpatient procedures. This is not a theoretical trend—it is a practical shift in post-procedure protocols, discharge expectations, and patient demand. Yet alternatives that reliably cover the pain window are still limited, forcing many clinicians to choose between under-treated pain and systemic medications they would prefer to avoid.
This creates a time-sensitive opportunity for non-opioid therapies that can reduce opioid exposure while maintaining comfort and function. A topical product that performs strongly in the recovery window fits directly into current prescribing priorities and aligns with what strategic buyers are actively seeking in the pain category.
02
WHY EXISTING TOPICALS FAIL
04
DE-RISKED ASSET
The topical pain category is large but scientifically narrow. Most products rely on legacy ingredients and commodity formulations - menthol, diclofenac, or standard lidocaine delivery - resulting in performance limitations that are well-known in real-world use. Some products can provide a quick sensation of relief but do not sustain it. Others may help with mild inflammation-related discomfort but are not designed to cover higher-intensity post-procedure pain.
As a result, topical options often miss what matters most in recovery: rapid onset, meaningful depth of relief, and sustained coverage across the post-surgical pain curve. That performance gap is the reason the category remains commercially large, yet still open to a differentiated product that performs materially better in the real recovery window.
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Most biotech programs enter the market with a hypothesis and limited human exposure, then spend years and capital proving basic clinical relevance. NEX-127 enters at a different point. It was developed through extensive real-world clinical use in a compounding setting, refined through repeat clinical application, and supported by thousands of documented patient uses under clinical supervision.
With core clinical validation already established, the remaining path is concentrated in execution - Phase II bridging and regulatory packaging - positioning the asset for near-term strategic licensing or acquisition discussions. For investors, this creates a rare biotech profile: later-stage entry, reduced scientific uncertainty, and a clearer path to transaction value.
| PIPELINE HIGHLIGHTS
RELIVRA SNA - ORPHAN DRUG
We have developed a unique, transdermal formulation based on modified flavonoids, specifically designed to target the primary cause of Skin Nodular Amyloidosis (SNA). We have created a novel treatment that could inhibit the amyloid accumulation directly at the site of the skin nodules, presenting a lasting solution for a desease which currently has no treatmnet.
A NOVEL APPROACH TO TREAT AN ORPHAN DISEASE
NEX-127
NEX-127 is first-in-class New Chemical Entity (NCE) topical analgesic designed to deliver rapid-onset and extended-duration pain relief from a simple, patient-friendly gel. It is built on a proprietary covalent mutual-prodrug architecture enabling coordinated skin penetration and enzyme-triggered local release of both actives at the site of application.
DESIGNED FOR POST-PROCEDURE AND WOUND PAIN
| ABOUT US
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We focus on improving pain management in clinical settings where current options remain limited, especially post-procedural and wound-related pain. Our mission is to expand access to effective, non-opioid pain relief solutions that can improve recovery outcomes while reducing reliance on systemic medications. We apply rigorous development standards and proprietary formulation technology to advance clinically validated programs that are designed for real-world use, scalability, and commercial relevance. Our lead asset, NEX-127, reflects this approach—combining clinical validation with a clear path to strategic partnering and broader patient access. We remain committed to responsible development that prioritizes patient safety, practical usability, and meaningful impact for healthcare systems and the communities they serve.
Our core strength is the ability to develop and scale sophisticated topical drug products, supported by dedicated in-house teams in formulation development, process chemistry, and analytical development. We combine strong science with disciplined execution—designing products that perform reliably in real clinical settings and can be produced consistently at commercial quality. We focus exclusively on pain, where we have built deep expertise and a proven development pathway. This focus allows us to move faster, make better technical decisions, and advance differentiated non-opioid solutions that can meaningfully improve how pain is managed.
MEET SOME OF OUR EXPERTS
Professor Uryash is a visionary scientist, researcher, and an associate professor at Mount Sinai Hospital Biotech Institute in Miami He has been at the forefront of pain research for over a decade Experienced Scientist, Director Of Research Development,
Medical Science Communicator, Founder and Educator with a demonstrated history of working in the pharmaceutical industry He is
skilled in U S Food and Drug Administration (FDA processes, IP development medical technology biomaterials, and formulation).
Dr. Steven Presser, MD
Steven C. Presser, M.D. is an experienced Beverly Hills fertility doctor who has presented and published numerous research abstracts & peer-reviewed publications, given seminars and lectured crowds and clinicians alike and has frequented radio talk shows. His areas of research & publications include ectopic pregnancy, nutrition, lifestyle and reproductive health, oocyte freezing and fertility preservation, human embryo co-culture methods. He was the recipient of Mead Johnson Laboratories, Purvis Martin Award for excellence in research.
Israel Vierma, MBA
A former marketing director of Johnson and Johnson, Israel Vierma is an expert in the sales of Advanced Medical Products. His career is based upon a platform of expert market knowledge, leadership skills and commercial experience with several of the world’s leading medical product providers. He has an MBA and dual engineering degree, with solid clinical knowledge and the ability to manage dynamic business development initiatives delivering innovative strategies, building teams that grow revenue and market share.
Dr. Ari Lamet, MD
Dr. Ari Lamet, MD, Director of The Broward Center For Gastrointestinal Disorders, is a distinguished expert and board-certified Gastroenterologist, with a specialized focus on the treatment of inflammatory bowel disease and ulcerative colitis. Dr. Lamet has authored or co-authored numerous articles and serves as a professor at Nova Southeastern University College of Medical Sciences. Dr. Lamet's innovative approach and extensive experience have positioned him as a leading authority in the field, making him an invaluable asset to our advisory board. His commitment to patient care and his relentless pursuit of novel therapeutic strategies underscore his dedication to improving the lives of those affected by these debilitating diseases.
Dr. Etan Marks, MD
Dr. Etan A. Marks, MD, Partner in Advanced Dermatology Surgery Center of South Florida is a distinguished pathologist with board certification in Dermatopathology, bringing a wealth of expertise to out advisory board. Dr. Marks has published over 20 articles in peer-reviewed journals, successfully managed multiple clinical trials and contributed to the development of regulatory skin oncology guidelines. His profound knowledge in diagnosing skin malignancies and extensive expertise in cellular and molecular techniques is important for promoting innovative treatments of Orphan Skin Diseases.
DIFFERENT AND SUPERIOR
Topical pain relief is a large and durable category, but most products still rely on legacy active ingredients and older delivery formats. In real clinical use, these options often fail to provide the combination patients need after procedures: fast relief that lasts, delivered locally without systemic exposure.
NEX-127 (Relivra™) was designed to address this performance gap through a differentiated drug and delivery approach. It is a New Chemical Entity (NCE) mutual prodrug—Naringenin-7-O-Hemisuccinate + Lidocaine—formulated in a thermosensitive topical gel that spreads easily during application and then sets on contact, helping the formulation remain localized at the treatment site. This delivery system is intended to support controlled local exposure and sustained performance across the post-procedural pain window.
The formulation strategy follows pharmaceutical development standards, emphasizing consistency, stability, and repeatable local delivery. The objective is straightforward: deliver clinically meaningful topical analgesia with a profile suitable for regulated drug development and broad clinical adoption.
Peer-reviewed publication remains the gold standard for validating clinical research, ensuring results are presented with rigor, transparency, and independent scientific scrutiny. It is one of the most trusted ways the medical community evaluates evidence supporting new therapeutic approaches and clinical claims.
Nexa Bioscience has published the latest human clinical trial results for NEX-127 (Relivra™) in reputable scientific and industry journals. This milestone strengthens clinical credibility, increases visibility within the medical community, and supports strategic partnering and acquisition discussions.
PEER REVIEWED PUBLICATIONS
CLINICAL TRIALS
Clinical validation is the foundation of any serious drug asset—and NEX-127 has already cleared the most important threshold: demonstrated performance in humans. These studies were designed to confirm what matters to regulators and strategic buyers: that the product can deliver meaningful pain relief, maintain a strong safety profile, and translate into real-world clinical utility. The results provide a clear basis for the next stage of development and support a focused, execution-driven path toward Phase II readiness.
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NEX-127 has been evaluated across multiple real clinical pain settings where current topical options routinely fall short—particularly in wound-related and post-procedural pain, where rapid onset and sustained relief are critical. Rather than relying on short-lived numbing or superficial symptom masking, the clinical work supports a differentiated profile: fast pain control with durability, designed for localized action with minimal systemic burden.
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Across completed human clinical validation, NEX-127 demonstrated a strong efficacy signal—showing clinically meaningful pain reduction and improved patient comfort. Importantly, the product is positioned as a non-opioid topical solution, offering the potential to reduce reliance on systemic pain medications in settings where opioids remain a default fallback. For both clinicians and payers, that combination—effective pain relief with opioid-sparing potential—represents a high-value therapeutic outcome.
Equally important, the clinical data support a clean safety profile appropriate for broad use. No material safety concerns emerged, reinforcing the product’s potential for adoption in high-volume clinical settings. This safety and tolerability profile is a key advantage in topical pain management, where many products either underperform clinically or become constrained by tolerability, systemic exposure, or limited duration.
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Taken together, the clinical evidence positions NEX-127 as a validated, de-risked drug asset—not a research project. With human confirmation already achieved, the remaining value creation is concentrated in targeted bridging and regulatory execution, creating a direct path toward strategic licensing or acquisition based on a credible clinical package rather than early-stage speculation.
PIPELINE AND COMMERCIALIZATION
- 4 DISTINCT PRODUCTS
- 3 PLATFORMS
- 1 ORPHAN DISEASE APPLICATION
Post-surgical pain remains one of the most common and costly problems in modern medicine—and the standard solutions are increasingly constrained. Health systems are actively reducing opioid exposure, yet patients and clinicians still face the same clinical reality: intense localized pain after procedures needs fast relief that lasts, without systemic side effects or dependency risk.
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Topical options have not kept pace with this need. Conventional lidocaine products provide short, surface-level numbing, often fading within hours and requiring repeated dosing. Anti-inflammatory topicals typically act more slowly and do not deliver immediate relief when patients need it most. As a result, providers frequently default to systemic drugs—despite well-recognized limitations in tolerability, safety, and real-world adherence.
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Nexa Bioscience was built to change that dynamic with NEX-127 (Relivra®), a first-in-class topical analgesic designed to deliver both rapid onset and extended duration from a single, patient-friendly gel application. NEX-127 is engineered as a New Chemical Entity (NCE) with a proprietary mutual-prodrug architecture in a thermosensitive gel, developed to support deep local delivery while maintaining low systemic exposure. The program is supported by extensive real-world clinical use and completed human clinical validation, establishing a differentiated platform positioned for broad surgical applicability.
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This is the next step in topical pain management: a modern, non-opioid approach built for real clinical workflows, where speed, duration, safety, and adoption all matter—and where strategic acquirers increasingly prioritize assets that can redefine standard of care.
PIPELINE: PRODUCTS
PIPELINE: MANAGEMENT PLATFORMS
NEX-127
01
First-in-class New Chemical Entity (NCE) topical analgesic designed to deliver rapid-onset and extended-duration pain relief
RELIVRA mRNA
02
Harnessing mRNA + LNP technology to promote tissue regeneration and pain relief, especially beneficial for orthopedic and post-surgical rehabilitation.
RELIVRA POSTBIOTIC
03
Embracing immune modulation and tissue regeneration for a holistic approach to pain relief.
RELIVRA ADVANCED EXCIPIENTS
04
Enhancing stability and safety by optimizing excipients, mitigating risks to the supply chain.
RELIVRA ADC
01
Merging pain-targeting antibodies with potent pain-relieving agents, offering a precise and effective approach to pain management.
RELIVRA PRP
02
Utilizing a Precision Research Platform to optimize pain management based on individual genetic and biomarker profiles.
RELIVRA MICRO TRIALS
03
Accelerating development through de-risked and incubated micro clinical trials, ensuring rapid optimization and validation.
R
04
Enhancing stability and safety by optimizing excipients, mitigating risks to the supply chain.