XOMA Corporation has acquired an economic interest in DSUVIA® (sufentanil sublingual tablet) from Talphera, Inc., for $8 million. DSUVIA® was approved in 2018 by the FDA for use in adults in certified medically supervised healthcare settings. In April 2023, Talphera divested DSUVIA® to Alora Pharmaceuticals for an upfront payment, a 15 percent royalty on commercial net sales, a 75 percent royalty on net sales to the U.S. Department of Defense (DoD), and up to $116.5 million in milestone payments.
In April 2020, DSUVIA® received Milestone C approval from the U.S. Department of Defense (DoD) for use in U.S. Army sets, kits, and outfits (SKOs) and was added to the DoD Joint Deployment Formulary in September 2020. Given the convenient sublingual delivery via a single dose applicator and its ability to provide effective pain relief for several hours, DSUVIA® could be an effective tool for use by military medics to treat injured personnel in contested environments.
Under the terms of the agreement, XOMA will receive 100 percent of all royalties and milestones related to DSUVIA® sales until the Company receives $20 million. Thereafter, XOMA fully retains the 15 percent royalty associated with DSUVIA® commercial sales, and the 75 percent royalties generated from DoD purchases will be shared equally between XOMA and Talphera, as will the remaining $116.5 million in potential milestone payments due from Alora Pharmaceuticals.
About DSUVIA (sufentanil sublingual tablet), 30 mcg
DSUVIA® is indicated for use in adults in certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with intravenous (IV) administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator (SDA) by healthcare professionals. Sufentanil is an opioid analgesic previously only marketed for IV and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile, when delivered sublingually, avoids the high peak plasma levels and short duration of action observed with IV administration.