Endo International plc has announced that it will be distributing Slayback Pharma LLC’s Prevduo™ (neostigmine methylsulfate and glycopyrrolate injection) on an exclusive basis in the U.S. market. Prevduo™ is a pre-filled syringe that was approved by the FDA in February 2023 for the reversal of nondepolarizing neuromuscular blocking agents (NMBA) after surgery, while also reducing the muscarinic effects that are associated with cholinesterase inhibition following NMBA reversal administration.
Endo Ventures Limited and Par Pharmaceutical, Inc., both of which are subsidiaries of Endo International, will be responsible for commercializing Prevduo™ through their Par Sterile Products business. The product is set to launch in June 2023 and will be the first and only FDA-approved neostigmine-glycopyrrolate combination product in the U.S.
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Neostigmine methylsulfate and glycopyrrolate have already been approved as single, active ingredient drug products in the U.S., and neostigmine is always administered with glycopyrrolate. However, the administration of these two drugs requires two separate syringes. Prevduo™ offers a ready-to-use solution that streamlines operations for hospitals by eliminating the need to prepare or transfer the product before patient administration. This can reduce waste and costs, optimize convenience and workflow, and reduce the chances of preparation error—all of which support quality patient care.
“Prevduo™ further strengthens our commitment to supporting healthcare providers and their patients through ready-to-use products that streamline operations,” said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. “We’re proud to partner with Slayback to bring this critical care product to market and help hospitals deliver quality patient care.”
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Ajay Singh, Founder and CEO of Slayback Pharma, added, “Following the development and FDA approval of Prevduo™, we’re pleased to partner with Endo and tap into Endo’s proven capabilities in commercializing injectable solutions, including ready-to-use products.”
However, there are certain contraindications and warnings to be aware of when using Prevduo™. The product is contraindicated in patients with hypersensitivity to neostigmine methylsulfate and glycopyrrolate or any inactive ingredients or with peritonitis or mechanical obstruction of the intestinal or urinary tract. The product should also be used with caution in patients with certain coexisting conditions, including coronary artery disease, congestive heart failure, cardiac arrhythmias, recent acute coronary syndrome, hypertension, myasthenia gravis, and hyperthyroidism.
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Neostigmine, a component of Prevduo™, is associated with bradycardia and the risk of blood pressure and heart rate complications, which are increased in patients with acute cardiovascular conditions. The product may also cause hypersensitivity or neuromuscular dysfunction, and it is important to differentiate between myasthenic crisis and cholinergic crisis caused by overdosage of neostigmine. Glycopyrrolate, another component of Prevduo™, is contraindicated in patients with glaucoma because it may cause mydriasis and increase intraocular pressure. Patients should also be warned not to participate in activities requiring mental alertness, such as operating a motor vehicle or other machinery.
Nonetheless, Prevduo™ offers a promising solution for hospitals to streamline their operations and deliver quality patient care, with Endo International’s distribution agreement with Slayback Pharma LLC meaning that this product will be more widely available in the U.S. market from June 2023.
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