The Advisory Council on the Misuse of Drugs (ACMD) has delivered comprehensive recommendations to the Home Office regarding the classification and scheduling of five medicines under UK drug control legislation, signalling ongoing efforts to balance therapeutic access with public safety.

In correspondence dated 13th August 2025, Professor Owen Bowden-Jones, Chair of the ACMD, outlined the council’s assessments of three growth hormone treatments and two neurological medicines, providing clarity on their potential for misuse and appropriate regulatory controls.

Growth Hormone Treatments Receive Class C Classification

The ACMD has recommended that three growth hormone agonists—somapacitan (Sogroya®), lonapegsomatropin (Skytrofa®), and somatrogon (Ngenla®)—should be controlled as Class C drugs under the Misuse of Drugs Act 1971. These medicines, all designated as orphan medicinal products, treat growth hormone deficiency in children and adults.

Drug classification decisions for these growth hormone medicines align with existing controls on similar treatments already regulated under Class C, including somatotropin, somatropin, and somatrem. The Medicines and Healthcare products Regulatory Agency (MHRA) reported minimal post-marketing misuse concerns, with somatrogon showing only minor non-compliance issues rather than genuine abuse.

The ACMD’s drug classification recommendations place all three medicines under Schedule 4 (Part 2) of the Misuse of Drugs Regulations 2001, maintaining consistency with current growth hormone medicine controls whilst ensuring appropriate medical access for patients with growth hormone deficiency.

Neurological Medicines Present Varied Risk Profiles

Two neurological treatments received contrasting recommendations from the council. Zuranolone (Zurzuvae®), awaiting UK approval for treating postnatal depression, demonstrated similarities to benzodiazepines in laboratory studies, prompting the ACMD to recommend Class C drug classification under Schedule 4 (Part 1) controls.

The synthetic neuroactive steroid showed euphoric and CNS depressant effects comparable to alprazolam in human studies, though its limited prescription scope—restricted to healthcare professionals experienced in perinatal psychiatry—may reduce misuse potential.

Conversely, ganaxolone (Ztalmy®), approved for treating the rare CDKL5 deficiency disorder in young patients, received no control recommendation. Despite animal studies suggesting reinforcing characteristics similar to benzodiazepines, the ACMD concluded that the medicine’s extremely limited use for rare childhood epilepsy presents minimal public health risks.

Monitoring and Risk Assessment Priorities

The council’s drug classification approach emphasises evidence-based assessment whilst maintaining vigilance for emerging misuse patterns. For ganaxolone, the ACMD recommended enhanced post-marketing surveillance, requiring the MHRA to monitor misuse indicators and resubmit evidence if abuse concerns arise.

These recommendations reflect the ACMD’s balanced approach to medicine regulation, recognising legitimate therapeutic needs whilst safeguarding against potential harm. The council’s systematic review process considers animal studies, human clinical data, and real-world evidence to inform appropriate control measures.

Professor Roger Knaggs, Chair of the ACMD Technical Committee, co-signed the recommendations alongside Professor Bowden-Jones, underscoring the technical rigour applied to each drug classification decision. The assessments draw upon comprehensive submissions from the MHRA, including both written evidence and oral presentations to council members.

Implementation and Legislative Changes

The Home Office will now consider implementing the recommended drug classification changes through legislative amendments to the Misuse of Drugs Act 1971 and associated regulations. These modifications ensure the UK’s controlled substances framework remains current with emerging pharmaceutical developments whilst maintaining public health protection.

The ACMD’s recent activity, including these five medicine assessments and an ongoing ketamine harms evaluation closing on 19th August, demonstrates the council’s continued commitment to evidence-based drug policy development in response to evolving therapeutic landscapes.

Source: dbrecoveryresources