Pioneering Solutions to the Growing Pain Management and Addiction Crisis

 

The US in the midst of an opioid epidemic. Each year millions of people are prescribed these highly addictive therapies to manage post-surgery and chronic pain and the consequences can be deadly.

Staggering statistics include:

  • Each year 160k Americans may develop addiction to opioid medications during standard pain management (Pino & Covington, 2019).
  • The CDC’s National Center for Health Statistics reported overdose deaths from opioids rising from approximately 51K in 2019 to almost 70K in 2020 (more than deaths caused by guns, car accidents or breast cancer).
  • The Council of Economic Advisers estimated in November of 2017 that the economic cost of the opioid crisis to the U.S. economy was $504.0 billion in 2015, or 2.8% of GDP that year.

According to the National Institute of Drug Abuse:

  • Roughly 21 to 29 percent of patients prescribed opioids for chronic pain misuse them.
  • Between 8 and 12 percent of people using an opioid for chronic pain develop an opioid use disorder.
  • An estimated 4 to 6 percent who misuse prescription opioids transition to heroin.
  • About 80 percent of people who use heroin first misused prescription opioids.

In reality, opioid therapies are commonly ineffective in managing chronic pain, often exacerbate pain symptoms and produce a rapid tolerance that requires regular dosage increases. Yet, they remain in high demand with Opioid and NSAID/COX2 therapies accounting for 52% of the pain management market—a $62 billion global market, with $30 billion spent in the United States.

The Catastrophic Impacts of the Opioid Crisis Require New Safe and Effective Pain Management and Addiction Treatments

Due to the growing awareness of Opioid medication risks, non-opioid pain management totaled $9.9 billion in 2017 and is estimated to reach $22.6 billion by 2022 due to the growing awareness of opioid medication risks.

Bexson is responding with non-opioid therapies designed to be safer than opioids, and efficacy on par with opioids for acute pain management.

Ketamine offers massive untapped potential in everyday pain management and has literature data showing efficacy that rivals strong opioids. Approved for use in anesthesia in 1970, at low doses Ketamine has a favorable safety profile and produces analgesia that has also been shown to block the processes that turn a short-term pain signal into lasting chronic pain conditions.

Despite Promising Potential, Ketamine Is Not Currently Available Outside of the Hospital or Clinic Due to Pharmacokinetic and Pharmacodynamic limitations.

Ketamine has been shown to help avert the development of hyperalgesia, a common process wherein appropriate pain in response to injury ratchets up to become its own chronic pain problem. Ketamine can arrest the development of chronic pain while treating acute pain directly. Unfortunately, opioids produce the exact opposite effect.

Bexson’s Formulation and Subcutaneous On-Body Delivery System Solves Many of the Problems Limiting Access to Ketamine for Pain Management

Bexson is developing a first of its kind wearable medical device with the potential to revolutionize how controlled medications are delivered to make them safer, more effective and tamper-resistant.

Bexson’s technology is modular by design, ideal for repurposing valuable medications to address pain management, addiction, and mental health illnesses. This innovative design allows for subcutaneous delivery and will provide safety and pharmacokinetic control to highly valuable medications in need of innovation.

Bexson is developing a first of its kind medical device with the potential to revolutionize how controlled medications are delivered to make them safer, more effective and tamper-resistant.

Bexson’s technology is modular by design, ideal for repurposing valuable medications to address pain management, addiction, and mental health illnesses. This innovative design allows for subcutaneous delivery and will provide safety and pharmacokinetic control to highly valuable medications in need of innovation.

Our technology optimizes drug delivery profiles to the realities of office-based treatment, providing notable medical economic advantages.

With our subcutaneous delivery systems we aim to address common weaknesses with oral, intranasal and intravenous drug administration:

          • Limitations from long and short half-life
          • Poor oral bioavailability
          • Narrow therapeutic index
          • Risk posed by excessive metabolite loading
          • Off-target side effects (e.g., nausea & vomiting)
          • Response variability
          • Diversion risk and misuse

Bexson’s Primary Focus

Reimagine Pain Management and Address the Opioid Crisis

BB106 – Subcutaneous Ketamine Administered by
On-Body Delivery System

 

Our lead project is a novel Ketamine therapy for acute pain management based upon a unique subcutaneous formulation paired with a pre-filled, presterilized, wearable patch delivery pump. This new delivery platform was designed to solve multiple pharmacokinetic issues and allow exquisite control over dosing to achieve at-home pain relief in multiple pain disorders.

Research and Development Overview 

On April 13, 2021 the USPTO issued a patent to Bexson Biomedical regarding formulation innovations applied to BB106, our subcutaneous Ketamine formulation.

Our lead formulation technology allows fine tuning of solution pH and osmolality, both key issues in tailoring treatments for subcutaneous delivery.  

While ketamine has remarkable therapeutic potential, its utility is limited by its short half-life and low-bioavailability when taken orally or intranasally. The company’s proprietary formulation, BB106, has the solubility and chemical properties to allow subcutaneous delivery. Bexson’s subcutaneous delivery platform allows for continuous or bolus delivery of highly bioavailable, therapeutically relevant doses.

Existing clinical care and research has established ketamine capacity to provide pain relief at doses that can be substantially lower than those used to treat depression or induce anesthesia. Lower doses can translate to fewer side effects and increased safety. In fact, ketamine is already used to great effect by pain physicians, but delivery options are limited, hampering broader solutions. Key opinion leaders in pain management express notable enthusiasm and interest in Bexson’s new low-dose subcutaneous Ketamine delivery platform.

Literature data shows Ketamine can help treat the following conditions:

 

        • Post Laminectomy Syndrome & Failed Back Syndrome
        • Acute Postoperative Pain
        • Acute and Chronic Migraine
        • Neuropathic Pain from Spinal Cord Injury
        • Fibromyalgia & Diffuse Connective Tissue Disease
        • Cervical Spine Trauma
        • Pain due to Nerve Injury
        • Chronic and Traumatic Neuropathy
        • Ischemic Limb Pain
        • Mechanical Allodynia
        • Post Herpetic Neuralgia
        • Trigeminal Neuralgia

A Safe and Effective Low-Dose Ketamine Strategy for Pain Management In the Home Environment Can Be a Game Changer In the National Opioid Crisis

With continued research, testing and medical rigor, we’re confident this patented technology can repurpose many existing medications and enable development of new chemical entities for controlled subcutaneous administration.

Bexson’s Secondary Focus

Address Rampant Addiction to Benzodiazepine

BB20X – Subcutaneous Flumazenal Administered by Our On-Body Delivery System

 

Studies demonstrate that slow, continuous infusion of Flumazenil can facilitate rapid Benzodiazepine discontinuation while controlling withdrawal symptoms. Yet, Flumazenil is currently only approved for emergency use.

Our formulation technology is the right solution to deliver Flumazenil conveniently with our OBDS technology in the home or clinic.

Additional Projects

Bexson’s proprietary delivery technology and formulation breakthroughs can help repurpose other valuable therapies to treat multiple large market indications.

We Continue to research Subcutaneous Delivery of Other Existing Compounds Based on the Following:

To Address Treatment Resistant Depression and Suicidality:

BB106 – Subcutaneous Ketamine In-office infusion by wearable device.

To Address PTSD and Chronic Suicidality:

BB30X – Subcutaneous Dimethyltryptamine (DMT) for in-office subcutaneous infusion.

Evolving Medicine Enhancing Lives

Bexson’s subcutaneous ketamine delivery system is our priority focus. However, our proprietary delivery technology and formulation breakthroughs are can help repurpose other valuable therapies to treat multiple large market indications.

Bexson Biomedical is developing a unique ketamine delivery system for pain disorders and mental health conditions. Our flagship project will deliver a proprietary subcutaneous formulation of ketamine via a minimally invasive, wearable, subcutaneous infusion pump to enable highly accurate delivery and dosing control.

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