Tersera Therapeutics LLC Reports Updated 2024 PACC Guidelines for PRIALT Administration

DEERFIELD, Ill.--TerSera Therapeutics LLC has announced that the 2024 Polyanalgesic Consensus Conference (PACC) guidelines continue to underscore the importance of non-opiate PRIALT in managing severe chronic pain. These guidelines build on previous versions, including the 2016 PACC guidelines, which endorsed PRIALT as a primary treatment option for both neuropathic and nociceptive pain.

The revised PACC Guidelines were published on May 16, 2024, in the journal Neuromodulation. Emphasizing the significance of individualized dosing, the updated guidelines outline several critical factors for initiating PRIALT therapy effectively. “The updated 2024 PACC guidelines offer clinicians recommendations on managing PRIALT therapy for patients grappling with severe chronic pain,” commented Dr. Gladstone C. McDowell II, an author of the guidelines and the former Medical Director of Integrated Pain Solutions in Columbus, Ohio. He added that having a non-opioid analgesic like PRIALT provides a valuable option to minimize the risks of dependence and addiction associated with opioid treatments.

Nancy Martin, MD, PharmD, Chief Medical Officer at TerSera, emphasized that the PACC guidelines panel continues to endorse PRIALT for patients with severe chronic pain unresponsive to other treatments.

The International Neuromodulation Society (INS) organized a team of esteemed clinical experts for a series of Polyanalgesic Consensus Conferences, which began in 1999, leading to the creation of these guidelines. The PACC guidelines are crafted by an international, multidisciplinary team specializing in intrathecal drug delivery.

Approved by the U.S. Food and Drug Administration (FDA) in 2004, PRIALT is designed for adults suffering from severe chronic pain when other treatments have failed, ceased to work, or are intolerable. PRIALT is administered intrathecally—directly into the spinal fluid—by a qualified physician. Unlike opioids, PRIALT is not classified as a controlled substance, avoiding issues of dependence and abuse.

The Centers for Disease Control and Prevention (CDC) estimate that nearly 17 million Americans experience severe chronic pain. Such pain can stem from various sources, including tissue damage (nociceptive) or nerve damage (neuropathic).

Treatment options for severe chronic pain are diverse and can include oral opioids, transdermal opioids, physical therapy, injection therapy, spinal cord stimulation, and spinal surgery. When these fail to control pain, intrathecal infusion treatment, where a pump surgically implants in the abdomen to deliver medication directly to the spinal cord, may be recommended. Besides PRIALT, morphine is the only other FDA-approved intrathecal infusion treatment for severe chronic pain.

TerSera Therapeutics, founded in 2016, is dedicated to oncology, acute care, and non-opioid pain management. The company's goal is to enhance patient outcomes through its portfolio of unique therapeutics.

PRIALT, an intrathecal solution and N-type calcium channel antagonist, is available in different vial sizes and concentrations. It is specifically indicated for adults with severe chronic pain unresponsive to other treatments.

While PRIALT offers significant benefits, it may cause serious side effects, including psychiatric symptoms and cognitive issues. Patients should immediately contact their doctor if they experience confusion, disorientation, or hallucinations, among other symptoms. PRIALT is contraindicated for individuals allergic to its ingredients or those with conditions making intrathecal injections unsafe.

Patients should also be aware that PRIALT can exacerbate depression, increasing the risk of suicide, especially in those over 65. Additionally, combining PRIALT with certain medications can heighten the risk of cognitive impairment. Meningitis and other infections can occur if the infusion device becomes contaminated, presenting symptoms such as fever, headache, and altered mental status.

PRIALT may induce unconsciousness or diminished alertness, so patients should avoid activities requiring full alertness, like driving. Common side effects include dizziness, nausea, confusion, and uncontrolled eye movements. It's crucial to discuss any adverse reactions with a healthcare provider.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!