Therapeutic Area:  Anesthesia

According to IQVIA MIDAS data (2010), more than 400 million people receive neuromuscular blocking agents annually either in the operating room to optimize surgical conditions, or in the intensive care unit to facilitate mechanical ventilation in those with patient-ventilator asynchrony. Neuromuscular blocking agents are also routinely administered before tracheal intubation to ensure optimal visualization and fewer complications. Additionally, due to greater numbers of laparoscopic abdominal procedures, there is an increasing need to use of neuromuscular blocking agents in the outpatient setting.

Typically, anesthesiologists or ICU specialists make the choice of NMBA, driven primarily by type of procedure, length, extent, and urgency of paralysis required, and patient characteristics such as weight, quality of airway, comorbidities, etc.

While neuromuscular blockers were first introduced into wide clinical practice in the mid-1900s the currently available agents have limitations and potential adverse effects such as bradycardia, cardiac arrest, anaphylactic reactions, hyperkalemia, malignant hyperthermia, and others. Agent selection and appropriate dosing are critical for patients with renal and/or hepatic impairment. Following a procedure, lingering effects of NMBAs may cause postoperative residual curarization (PORC) which can lead to respiratory failure and other serious complications. Physicians seek to balance safety with critical elements such as time to onset, speed of recovery, duration of effect, and ease of reversal. Full and complete reversal of neuromuscular blockade is essential to positive patient outcomes.

Innovation in this area has been severely limited in the past few decades. The most notable new entrant has been sugammadex (Bridion®, Merck), a rapid-acting reversal agent, capable of reversing the effects of non-depolarizing aminosteroid NMBAs rocuronium and vecuronium. Sugammadex was approved for use in the EU in 2008 and received US FDA approval in 2015. It has garnered fast uptake and broad utilization due to its predictability and the ability to extend the range of blockade reversal.

We believe that our novel intermediate-acting and ultra-short acting NMBAs and unique reversal agent will meet significant unmet needs within this market and give physicians new alternatives in a wide array of procedures and surgical settings.