NPRA Has Approved Six Methadone Products For Opioid Abuse

Health Minister Khairy Jamaluddin says the ministry is currently not conducting any trials for ketum or marijuana.

KUALA LUMPUR, Nov 11 — The National Pharmaceutical Regulatory Agency (NPRA) has so far approved six methadone products, used to treat people with chronic opioid abuse, as part of the Ministry of Health’s (MOH) harm reduction programme.

Health Minister Khairy Jamaluddin, in a written parliamentary reply today, said the registered products include Aseptone Syrup 5mg/ml, Alphadone Syrup 5mg/ml, Alphadone Syrup 10mg/ml, SW Methadon Syrup 5mg/ml, Bennaston Syrup 5mg/ml, and Adecure Syrup 5mg/ml.

Khairy said methadone is used for Medically Assisted Therapy (MAT) courses, specifically for individuals who are dependent on opioids. “Similar to other treatment of chronic diseases such as diabetes and hypertension, methadone therapy is a lifelong treatment.”

He said this in response to Permatang Pauh MP Nurul Izzah Anwar’s request for details on medicines approved for MOH’s harm reduction programme and whether the ministry is conducting any clinical trials on the use of ketum (kratom leaves) and marijuana.

Currently, the MOH is not conducting any trials for ketum or marijuana. However, pre-clinical trials for ketum leave extracts conducted by the Institute for Medical Research (IMR) suggest that the extracts are safe for use within a short time frame. 

Similar studies were conducted by the Forest Research Institute Malaysia (FRIM), Universiti Sains Malaysia (USM) and Universiti Putra Malaysia (UPM).

However, Khairy said pre-clinical data remains insufficient for the formulation of ketum leave extracts to enter the clinical trial phase, including a longer-term study on the safe use of the leave extracts.

“The main challenge here is obtaining regular raw materials from suppliers. Studies on ketum require sufficient raw materials from stable sources to produce standardised extracts with similar content for all pre-clinical studies.

“Continuous production of standardised extracts from ketum raw materials suitable for pre-clinical and clinical studies is essential to produce high-value products,” Khairy said.

On marijuana, Khairy said the MOH has yet to conduct any laboratory study on its use. However, the IMR has conducted a scoping review on hemp titled “Cannabis sativa subsp. sativa’s pharmacological properties and health effects: A scoping review of current evidence” that was published in the PLOS One peer-reviewed journal in January this year.

Khairy recently acknowledged, via a Parliament written reply, the use of cannabis for medicinal purposes in Malaysia, saying that existing legislations that regulate cannabis and its by-products in Malaysia do not prohibit the use of cannabis for medicinal purposes.

He said a product containing cannabis that is used for human medicinal purposes can be imported and consumed in Malaysia if that product complies with the requirements of the law.

The Malaysian Association for the Study of Pain (MASP), in response to the statement, maintained that there is still insufficient evidence from high-quality research to endorse the general use of cannabis for the treatment of pain.

The MASP recommends that authorities look to the experience of Thailand, which legalised the use of medical marijuana in early 2019, citing the need for “well-planned strategies” before policies legalising medical cannabis are implemented.

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