Targeted Drug Delivery - About the Therapy (2024)

LESS PAIN. FEWER SIDE EFFECTS.

Targeted drug delivery (also known as intrathecal drug delivery) uses the SynchroMed^TM II infusion system to manage chronic pain, including intractable cancer pain. Unlike oral medications that must be absorbed systemically and cross the blood-brain barrier to reach pain signals, targeted drug delivery interrupts pain pathways at their source in the cerebrospinal fluid and spinal cord. An implanted, programmable pump and catheter release prescribed amounts of pain medication directly into the intrathecal space.

Intrathecal drug delivery enables patients to experience pain relief using a fraction of an oral medication dose,^1-3 which can help to minimize the uncomfortable and sometimes intolerable side effects (e.g., drowsiness, dizziness, nausea, vomiting and constipation) that often accompany pain medication taken orally.^2-5

Targeted drug delivery also can provide pain relief in patients who cannot achieve adequate analgesia even with high doses of oral opioid medications.

This therapy is not for everyone. In addition to risks related to a surgical procedure, and drug related adverse events, pump or catheter problems can cause serious or fatal drug overdose or underdose, and may require corrective surgery. For additional safety information, please refer to Indications, Safety, and Warnings.

AN ALTERNATE ROUTE OF DELIVERY

Millions of Americans are affected by pain and have been prescribed systemic opioids (typically oral) as part of their treatment plan by healthcare providers.⁶ This is despite limited evidence on the benefits of long-term systemic opioid therapy and evidence that long-term systemic opioid therapy is associated with increased risk for opioid misuse or addiction.⁷

The Control Workflow℠ for targeted drug delivery (TDD) is an approach to help eliminate systemic opioids and provide effective pain relief. The purpose of this workflow is to provide a treatment option for chronic pain using low-dose TDD. Patients should receive appropriate pain treatment based on careful consideration of benefits and risks of treatment options. TDD has demonstrated a substantial reduction in the amount of drug required to effectively manage chronic pain. By having an outlined workflow, we are hoping to reduce perceived barriers to the TDD therapy.³

The implanted pump stores and dispenses medication inside the body, reducing the opportunity for diversion of the drug, for misuse by individuals who are not prescribed the opioids. Additionally, the physician programs the pump to deliver a certain amount of medication, allowing more physician control compared to systemic opioid therapy, reducing the opportunity for misuse of prescribed opioids.

Targeted drug delivery with the optional myPTM™ personal therapy manager allows patient-activated, bolus dosing of morphine within physician parameters —to control — unpredictable pain, and can result in decreased intake of supplemental oral opioids.¹⁰

BENEFITS OF TARGETED DRUG DELIVERY

Benefits of treating chronic intractable pain with targeted drug delivery include:

• Effective pain relief^2,11
• Reduced or eliminated use of oral pain medicines^2,11
• Improved ability to function and participate in day-to-day activities¹²
• Fewer side effects compared to oral medication⁵
• Patient satisfaction^10,11
• Cost benefits^13,14

MANAGEMENT OF INTRACTABLE CANCER PAIN

Cancer patients may benefit from targeted drug delivery, an alternate route of delivering pain medication. For example, based on data from a randomized clinical trial, the proportion of subjects who achieved reductions in pain and opioid-related toxicity was greater in patients who received aSynchroMed™ II drug infusion system compared to those who received comprehensive medical management only.⁵

Research shows:

• A majority of patients experience pain during their course of cancer treatment, and cancer pain impairs quality of life and function
• The cost of inadequate pain control and the related side effects of pain medications is high, both in terms of impaired function and quality of life
• Pain interferes with activities of daily living

RISKS OF TARGETED DRUG DELIVERY

Surgical complications are possible and include infection, headache, spinal fluid leak, meningitis, and paralysis. Possible complications include the catheter or pump moving within the body or eroding through the skin which may lead to additional surgery. The catheter could leak, tear, kink, or become disconnected. The pump could stop because it has reached end of service or because of failure of another of the part of the infusion system. Any of these situations may cause symptoms to return and may require additional surgery. Device malfunctions may result in clinically significant overdose or underdose. Acute massive overdose may result in coma or fatality. An inflammatory mass can form at the catheter tip and result in serious neurological impairment, including paralysis. The therapy may not meet the patient's expectations or may lose effect. Electromagnetic interference (EMI) and magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate. See SynchroMed™ product labeling for more information.