You can now invest in SafeRX through our SEC-qualified Regulation CF Offering. Our offering is open to all investors—everybody and our entire community, not just institutions. Our investment minimum is just $500. Please see our offering page for details and the link to invest

Welcome to SafeRx⁠—
an answer to the American opioid crisis. We’re on a mission to create safer, healthier communities with far fewer overdoses.

MISSION

SafeRx was founded with one mission in mind:
to reduce the risk of prescription opioid overdose.

The opioid crisis represents one of the greatest national public health emergencies of our time, ravaging communities throughout this country for decades. And unlike COVID, there is no vaccine on the way; there will never be a “silver bullet” for this intricate problem. But SafeRx has developed a solution to a previously unaddressed dimension of the crisis that is responsible for thousands of fatal prescription overdoses every year…the combination of opioids with alcohol.

The opioid crisis is fueled by alcohol.

According to data from the CDC, 22.1% of fatal prescription opioid overdoses are related to concurrent alcohol consumption1. And research has shown that long term opioid patients with a history of alcohol problems are five times more likely to overdose on their medication2.

Because when alcohol is consumed with an opioid, these substances interact in the body to produce much more intense suppression of the nervous system…so intense the brain can actually forget how to breathe.

Yet despite these risks and unequivocal recommendations from health authorities for opioid users to avoid all alcohol consumption, research has shown that more than one third of patients on long term opioid therapy admit to drinking with their medication 3, 4, 5 , 6.

As these data show, prescribing physicians currently have no effective means of preventing their patients from making this dangerous, all too often deadly mistake.

But thanks to SafeRx Pharmaceuticals’ patented new platform of alcohol-resistant opioids (AROs), they soon will.

ALCOHOL-RESISTANT OPIOIDS (AROs): HOW THEY WORK

Along with the prescription opioid analgesic, ARO products include an enzyme blocker known as an ALDI that interferes with the metabolism of alcohol but otherwise remains essentially inactive in the body.

An FDA-approved opioid, which acts as an analgesic (painkiller). These are identical to opioid compounds that are currently prescribed to patients.

An FDA-approved ALDI— Disulfiram (the active ingredient in Antabuse™), which acts as an alcohol deterrent.

A matrix-based formulation, meaning the opioid and ALDI must be taken together and cannot be separated.

If taken as directed, the opioid will act as an analgesic, and the alcohol deterrent will produce no effects.

However, if the patient consumes alcohol with the medication, the ALDI produces a powerful, noxious reaction characterized by severe flushing, headaches, nausea, and vomiting (known as the disulfiram-ethanol reaction), thereby deterring additional alcohol consumption.

PATH TO FDA APPROVAL

Because all of the active pharmaceutical ingredients included in our ARO platform of products have already been FDA-approved for their intended uses, SafeRx can leverage an expedited FDA application pathway known as a 505(b)(2).

This eliminates the need to duplicate the costly, time- consuming clinical trials that have already been performed on the original parent drugs, dramatically reducing the scope of new data needed to apply for approval of these ARO combination products.

Through this path, we expect to file new drug applications for our first two ARO products, OxARO™ IR and MethARO™ IR, in less than two years. And because these products address a national public health emergency, they should qualify for Priority Review, cutting FDA review time to less than six months.

This means our ARO products could start saving lives in less than 2 ½ years.

COMPETITIVE ADVANTAGES

First Mover with Intellectual Property
  • Paradigm-shifting new class of alcohol-resistant opioids that are expected to save thousands of lives.
  • Issued USPTO utility patents (#10,478,408 and #10,881,625); enforceable through 2038.
Disruptive Solution to a National Public Health Emergency
  • Previously unaddressed dimension of the opioid crisis with no effective alternatives.
  • Reduces medico-legal liability for opioid prescribers.
Time-Efficient
  • New drug applications via 505(b)(2) pathway expected in less than 2 years.
  • Drugs will qualify for Priority Review with FDA (review time < 6 months).
Capital-Efficient
  • Abbreviated regulatory pathway; clinical trials limited in size/scope.
  • No costly technology required; “virtual pharmaceutical company” model.
Quality Team
  • Sophisticated, mission-driven founding team and board.
  • Extensive industry experience and track record of success.

INVESTORS

We anticipate a total need of only $15 million to achieve FDA approval of our two inaugural ARO products (OxARO™ IR and MethARO™ IR).

We are dividing this capital raise into two rounds.
Our current series A round aims to raise $5 million through a Regulation CF offering (for terms, click here).
As we move closer to approval, we plan to raise another $10 million in Series B financing, with updated terms reflecting a progressive anticipated increase in corporate valuation as key development program milestones are achieved.

Following FDA approval—or possibly before (e.g., after NDA submissions)—we will select from among multiple possible go-to-market strategies.

Because no other effective solutions to this critical dimension of the opioid crisis exist, once approved these proprietary ARO products are expected to achieve exclusive access to a greater than $10 billion addressable annual domestic market, allowing for a range of commercialization options.
A licensing-based agreement with a trusted, established pharmaceutical partner is considered the most likely path.
Sale of the ARO platform technology or the company will be considered if the terms of such an offer are in the best interest of our investors and the communities we are committed to serving.

With profit earned under an anticipated licensing agreement, SafeRx intends to both:
  • Issue special annual dividends to shareholders, and
  • Fund development programs of the other products in the existing IP pipeline, including:
  • Our ARO platform (HydARO™ IR, MorphARO™ IR, OxARO™ ER, HydARO™ ER, MorphARO™ ER).
  • Our patent-pending ARZ platform of products, designed to reduce the risk of alcohol-mediated complications associated with NBBRAs, a widely prescribed class of sleeping pills (including Ambien™, Lunesta™, and Sonata™).
And as the FDA is widely regarded as the gold standard regulatory authority, following approval we also expect to gain swift access to markets in the European Union, India, Canada, and Mexico.
  • International patent applications for SafeRx technology are currently pending in these countries.
The investor offering page and link to the form C are available here.

LEADERSHIP



  • Founding Team
Michael Presti, MD PhD
Michael Presti, MD PhD
Founder-CEO
Ray Sison
Ray Sison
Chief Product Officer


  • Advisory Board
Jamie Grooms
Jamie Grooms
Marlo Tan Walpole
Marlo Tan Walpole
Jim Parrino, MBA PhD
Jim Parrino, MBA PhD