Prialt
PRIALT (Ziconotide Intrathecal Infusion) for Severe Chronic Pain in patients for whom intrathecal (IT) therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies or IT morphine.
PRIALT is a Novel Non-Narcotic Treatment Based on Marine Snail Peptide Blocks Pain Signals.
PRIALT(R) is Approved for use only in the Medtronic SynchroMed(R) EL, SynchroMed(R) II Infusion System and Simms Deltec Cadd Micro(R) External Microinfusion Device and Catheter.
Prialt selectively blocks the nerve channels responsible for transmitting pain signals. This drug is part of a new class known as N-type calcium channel blockers. It is known chemically as ziconotide.
Prialt has been studied in patients with cancer, AIDS and other chronic pain, such as back pain. More than 1,200 patients took part in three clinical trials.
There are side effects, and the FDA is including a “black box” warning – the government’s strongest warning short of a ban. The four most frequently reported adverse events associated with PRIALT were dizziness, nausea, confusion, and headache. When PRIALT was used with an external pump, there was a higher incidence of meningitis.
PRIALT has been evaluated as an IT infusion in more that 1,200 patients participating in chronic pain trials. The longest treatment duration to date is more than seven years. Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Patients with a pre-existing history of psychosis should not be treated with PRIALT. All patients should be monitored frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. PRIALT therapy can be interrupted or discontinued abruptly without evidence of withdrawal effects in the event of serious neurological or psychiatric signs or symptoms.
The idea for the drug came from a snail called the Conus magus that lives in the South Pacific, which paralyzes its victims with venom after capturing them, the company said. Researchers set out learning how to develop a drug based on this venom and eventually copied the amino acid sequence.