Is Ziconotide legal in the United Kingdom?

A cone snail peptide approved in 2004 for severe chronic pain, given only by infusion into the spinal fluid through an implanted pump, with a boxed warning for severe psychiatric symptoms and neurological impairment. In its cancer and AIDS pain trial, 111 patients, mean pain score fell 53.1 percent against 18.1 percent on placebo. There is no oral, injected or topical version and there cannot be one.

Ziconotide is the synthetic form of a 25-amino-acid peptide from the venom of the marine cone snail Conus magus. The FDA approved it in December 2004 under NDA 021060 for the management of severe chronic pain in adults for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine.

Mechanism: A selective antagonist of N-type voltage-gated calcium channels, which sit on the presynaptic terminals of primary nociceptive afferents in the dorsal horn of the spinal cord. Blocking calcium entry at those terminals prevents release of the neurotransmitters that carry the pain signal to second-order neurons.

Regulatory history: FDA-approved on 28 December 2004 under NDA 021060, for the management of severe chronic pain in adults for whom intrathecal therapy is warranted and who are intolerant of or refractory to other treatment. Intrathecal infusion is the only approved route. The label carries a boxed warning for severe psychiatric symptoms and neurological impairment.

Licenses medicines for the UK market. A compound without a marketing authorisation is an unlicensed medicine, which can only lawfully be supplied for human use through a prescriber under the specials scheme, not sold as a research product.

The classification above is the The Longevity Archive reading of Medicines and Healthcare products Regulatory Agency listings for Ziconotide at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.