KUALA LUMPUR, Nov 12 — Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) previously approved in 2014 a prescription medicine derived from cannabis to treat muscle spasms and spasticity from multiple sclerosis.
But Sativex — an oromucosal spray of a formulated cannabis extract with cannabidiol (CBD) as well as THC, the psychoactive chemical component in cannabis — was taken off the Malaysian market three years later as it was not commercially viable. Sativex was developed by GW Pharmaceuticals, a maker of cannabinoid therapeutics based in Ireland.
This means Malaysia currently has no registered marijuana-based treatment, although Health Minister Khairy Jamaluddin recently acknowledged the use of cannabis for medicinal purposes in the country.
He said existing legislations that regulate cannabis and its by-products in Malaysia, including the Dangerous Drugs Act 1952, Poisons Act 1952 and the Sale of Drugs Act 1952, do not prohibit the use of cannabis for medicinal purposes.
“The only CBD drug NPRA has registered so far was the Sativex oromucosal spray (MAL14095053ACRZ) in 2014, for treatment in patients with moderate to severe spasticity due to multiple sclerosis, who have not responded adequately to other anti-spasticity medication.
“This product has been withdrawn by the product registration holder (PRH) on July 17, 2017, [as] the product was not commercially viable, thus no CBD drug is registered with the Drug Control Authority (DCA) since,” the NPRA said in response to CodeBlue’s queries.
Spasticity is a symptom of multiple sclerosis, a condition that causes damage to the central nervous system, that causes muscles to feel stiff and difficult to move, while a spasm is a sudden stiffening of a muscle that may cause a limb to jerk.
CBD is one of over 80 chemical compounds, or cannabinoids, in the Cannabis sativa plant. Apart from CBD, the other most commonly known compound is the delta-9-tetrahydrocannabinol (THC), well known for producing the “high” associated with marijuana use, according to the United States’ Food and Drug Administration (FDA). However, unlike THC, CBD is not psychoactive.
The NPRA said the Drug Registration Guidance Document (DRGD) serves as the reference guide for the registration processes, including aspects relating to the quality control, inspection and licensing as well as post-registration activities of medicinal products.
The requirements for quality, safety and efficacy (including non-clinical and clinical data) of CBD products, including those containing cannabis, follows the general requirements of product registration as outlined in Appendix 3 of the DRGD.
In the context of clinical data, the NPRA said data on efficacy and safety from Phase Three clinical studies are generally required to support the registration of a new chemical entity, whereby the study designs and outcome measures should be justified.
The US’ FDA has approved only one CBD drug product, Epidiolex, a prescription medicine to treat seizures associated with two rare and severe forms of epilepsy, Lennox Gastaut syndrome and Dravet syndrome, as well as seizures from tuberous sclerosis complex, a rare genetic disease. Epidiolex is an oral solution also developed by GW Pharmaceuticals.
When asked if the NPRA will consider registering Epidiolex if an application is submitted, the agency said all applications will be evaluated and the final decision on the registration of the product will be subjected to the decision of the DCA.
