The FDA has recently approved two new medications for managing pain – ziconotide intrathecal infusion (Prialt) and pregabalin capsules (Lyrica).

Prialt, developed by scientists at Élan Corporation, has been approved for the management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or resistant to other treatment such as systemic analgesics, adjunctive therapies, or IT morphine. Prialt is approved for use only in the Medtronic SynchroMed®, SynchroMed® II Infusion System and Simms Deltec Cadd Micro® External Microinfusion Device and Catheter. It is the first new IT analgesic approved in more than two decades.

Prialt is in a class of non-opioid analgesics known as N-type calcium channel blockers; research suggests it works by targeting and blocking N-type calcium channels on nerves that ordinarily transmit pain signals. Prialt is the synthetic equivalent of a naturally occurring chemical found in marine snails and is not associated with addiction. The safety of Prialt was established in more than 1,200 patients, including those with pain related to failed back surgery, cancer, AIDS, and non-malignant causes. The majority of adverse events were mild or moderate. The four most frequently reported adverse events were dizziness, nausea, confusion, and headache. The longest treatment duration to date is more than seven years.

Lyrica, developed by scientists at Pfizer Inc., has been approved for the management of neuropathic pain associated with diabetic peripheral neuropathy (DPN) and postherpetic neuralgia (PHN). It is the first FDA-approved treatment for both these neuropathic pain states. It is expected to be classified as a controlled substance in a category with lower potential for misuse or abuse relative to controlled substances in other categories.

The safety of Lyrica was established in more than 9,000 patients. In all clinical trials, adverse events were mild to moderate. Among the most common side effects associated with Lyrica were dizziness, drowsiness, dry mouth, peripheral edema, blurred vision, and difficulty concentrating. Pain relief was sustained in studies of up to 12-weeks duration.

Both of these medications led to pain relief in as early as the first week of treatment in some patients. Also, both of their discontinuation rates due to adverse events were low or comparable to placebo. Prialt has just been made available to physicians and patients in the US. Lyrica will be available in the near future.

If your indications are among those listed above and/or if you want to learn more about how either of these treatment options may help you, we encourage you to contact Élan or Pfizer directly. Information about Prialt, including prescribing information and comprehensive support services, is available through 1-888-PRIALT-1 and at www.Prialt.com. Information about Lyrica, including how to be among the first to receive the final label for prescribing information, may be obtained through 1-866-4-LYRICA and at www.Lyrica.com. Both phone numbers are toll-free.