Countdown toNOPAIN Act:

28

Days

ASP+6% reimbursement for EXPAREL effective January 1, 2025, when billing with code J0666 across all outpatient surgical settings

Proprietary multivesicular liposome (pMVL) encapsulates drugs, preserving their molecular structure, and releases them over a desired period of time

HOW pMVL WORKS

The pMVL carrier matrix consists of microscopic, spherical, lipid-based particles composed of a honeycomb of numerous, non-concentric, internal aqueous chambers containing the encapsulated active agent

The pMVL carrier matrix consists of microscopic, spherical, lipid-based particles composed of a honeycomb of numerous, non-concentric, internal aqueous chambers containing the encapsulated active agent. Each chamber is separated from adjacent chambers by lipid membranes. Following injection, the pMVL particles release the active agent over an extended period of time due to erosion and/or reorganization of the lipid membranes.

  • pMVL offers flexible delivery and can be designed to offer an immediate-release dose followed by sustained delivery
  • The ready-to-use aqueous solution works with narrow gauge needles and pen systems
  • pMVL membrane components are natural, well-tolerated, and cleared by normal metabolic pathways
  • pMVL permits systemic delivery of medications by releasing the drug into the bloodstream via the interstitial space
    • Locally, pMVL can release the active agent into a body compartment, such as a wound

to deliver controlled levels of active agents1

of naturally occurring, biocompatible lipids2-4

pMVL technology delivers bupivacaine over time for extended analgesia

the active agent in a suspension of multivesicular liposomes

the active agent over time1

Our pMVL extended-release drug delivery technology can be applied to both small and large molecules, potentially improving patient care by providing a unique solution for medications that:

  • Need to be administered by continuous infusion or frequent multiple injections
  • Have a short duration of action or problematic side effects associated with peak concentrations

We have demonstrated that small and large molecule compounds can successfully be encapsulated into pMVL, including:

  • Traditional injectable pharmaceuticals
  • Proteins
  • Peptides
  • Antisense oligonucleotides
  • DNA

We are leveraging the proven safety, flexibility, and customizability of our pMVL technology for acute, sub-acute, and chronic pain applications. The current opioid crisis was triggered by a pain epidemic. Eliminating opioids will not address the significant unmet need for new tools and strategic approaches for managing pain. We have selected two pMVL-based programs for clinical development.

The first is the intrathecal or subarachnoid delivery of a pMVL-based local anesthetic other than bupivacaine for acute and chronic pain. We believe this approach may provide an alternative to the use of intrathecal or subarachnoid opioids typically delivered by pumps and catheters.

The second clinical compound we have selected is Dexmedetomidine-pMVL. With this product, we see the target market as end-of-life pain and painful conditions in the elderly. We believe the extended delivery of a therapeutic dose of dexmedetomidine has the potential to offer patients mental acuity and quality of life while also providing adequate pain control.

Graph comparing EXPAREL®, DepoTXA, and DepoMLX
References
  1. Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012;19(5):530-536.

  2. Angst MS, Drover DR. Pharmacology of drugs formulated with DepoFoam: a sustained release drug delivery system for parenteral administration using multivesicular liposome technology. Clin Pharmacokinet. 2006;45(12):1153-1176.

  3. Kohn FR, Malkmus SA, Brownson EA, Rossi SS, Yaksh TL. Fate of the predominant phospholipid component of DepoFoam drug delivery matrix after intrathecal administration of sustained-release encapsulated cytarabine in rats. Drug Deliv. 1998;5(2):143-151.

  4. Richard BM, Newton P, Ott LR, et al. The safety of EXPAREL® (bupivacaine liposome injectable suspension) administered by peripheral nerve block in rabbits and dogs. J Drug Deliv. 2012;2012:962101.