Pipeline
SyB P-1501
Summary
SyB P-1501

SyB P-1501 is a patient-controlled iontophoretic transdermal system providing on-demand systemic delivery of analgesia, for short-term management of acute post-operative pain in adult patients during hospitalization. A patient recovering from surgery in the hospital simply presses the button on the credit-card-sized device attached to the upper arm or chest, and a certain amount of ionized drug is delivered transdermally to achieve an analgesic effect.
SymBio acquired the exclusive development and distribution rights for SyB P-1501 in Japan from U.S. based The Medicines Company on October 2, 2015.
The number of patients in Japan requiring post-operative pain-management by patient-controlled analgesia (PCA) is estimated to be approximately one million a year. SyB P-1501, a non-invasive, needle-free, pre-programmed administration method, is expected to substantially reduce the physical and mental burden on patients by achieving an analgesic effect in a rapid and secure manner, while reducing labor and other costs of medical institutions given its superiority in terms of simplicity and safety.
SyB P-1501 was approved by the U.S. Food and Drug Administration (FDA) on April 30, 2015, and by the European Medicines Agency (EMA) on November 20, 2015.
In Japan, a phase I study for SyB P-1501 targeting healthy volunteers has been completed with a favorable level of safety confirmed, and SymBio has plans underway to initiate a phase III study. Establishment of innovative PCA methods using SyB P-1501 will improve the level of treatment satisfaction and QOL of patients undergoing treatment for post-operative pain.

Current status of acute post-operative pain-management

In general, surgical patients can experience various types of pain, thus effective post-operative pain control through rapid and safe analgesia is essential to enhance the post-operative treatment satisfaction and QOL of patients. Pain is a sensation that only the patient can understand, and it is difficult to objectively evaluate pain level. In addition, the degree of post-operative pain experienced and amount of pain medication required can differ between patients who undergo the same surgical procedure, hence awareness of the importance and necessity of post-operative pain-management on an individual basis in the medical field is required.
Medical institutions have introduced PCA, a method of pain control in which patients self-administer predetermined doses of analgesic medication via epidural or intravenous administration to relieve their pain. Healthcare professionals set up a programmable PCA pump as a dedicated device, and surgical patients self-activate an effective and safe amount of medication when they experience pain.
While the conventional PCA method is advantageous in enabling patients to administer analgesic agent as soon as they experience pain, (1) it places a physical and mental burden on patients due to invasiveness of the injection needle, and (2) involves substantial costs for medical institutions including the time required for healthcare professionals to maintain and manage the pump. SyB P-1501 is an alternative drug for PCA that solves these disadvantages for patients and medical professionals, delivering analgesia in a non-invasive, needle-free, safer and more convenient manner.