Is Risperidone (antipsychotic medication) available as a subcutaneous formulation?

Risperidone Subcutaneous Formulations

Risperidone is now available in subcutaneous formulations, offering an alternative administration route for patients requiring long-term antipsychotic therapy. 1, 2

Available Subcutaneous Formulations

• RBP-7000 (PERSERIS™): FDA-approved once-monthly subcutaneous risperidone that doesn't require oral supplementation when initiated 3

  • Administered in the abdomen using an 18G 5/8-inch needle
  • Available in 90mg (equivalent to 3mg oral daily) and 120mg (equivalent to 4mg oral daily) doses
  • Requires refrigeration and warming to room temperature before administration

• TV-46000 (UZEDY™): Recently approved (2023) subcutaneous risperidone formulation 4

  • Can be administered once monthly or once every 2 months
  • Significantly delays relapse compared to placebo
  • Uses a copolymer-based drug delivery technology

Clinical Efficacy and Advantages

• Subcutaneous risperidone formulations have demonstrated efficacy in clinical trials for schizophrenia 4
• TV-46000 prolonged time to relapse by 5.0 times (monthly dosing) and 2.7 times (bi-monthly dosing) versus placebo 4
• RBP-7000 showed superiority to placebo in reducing PANSS total scores in acute schizophrenia 3
• These formulations offer advantages over traditional oral medications:
  • Improved adherence
  • Consistent drug levels
  • No need for daily medication administration
  • Some formulations don't require oral supplementation

Side Effects and Monitoring

• The safety profile is consistent with what is known about oral risperidone 4

• Most common adverse reactions include:

  • Injection site reactions (nodules: 7% with TV-46000 vs 3% with placebo) 4
  • Weight gain (4-6% with TV-46000 vs 2% with placebo) 4
  • Extrapyramidal symptoms (3-5% with TV-46000 vs 0% with placebo) 4
  • Sedation/somnolence 3

• Injection site pain typically decreases rapidly (from mean score of 27 at 1 minute to 3-7 at 30-60 minutes post-injection) 3

Clinical Applications

• Appropriate for patients with:

  • History of poor medication adherence
  • Schizophrenia requiring long-term treatment 5
  • Bipolar disorder requiring maintenance therapy 2
  • PTSD-related nightmares (though typically oral formulation is used for this indication) 5

• Subcutaneous formulations may be particularly valuable for:

  • Patients who prefer less frequent dosing
  • Those who have difficulty with intramuscular injections
  • Individuals requiring consistent medication levels

Practical Considerations

• Different from traditional oral risperidone (which is not available in subcutaneous form)
• Differs from older intramuscular long-acting risperidone formulations
• Requires proper storage conditions (refrigeration for some formulations)
• Administration technique is specific to each formulation
• Some formulations (like RBP-7000) require preparation steps before injection

Emerging Options

• BB0817: A 6-monthly subcutaneous implant of risperidone under development 1
• Additional formulations are in various stages of clinical development 2

These subcutaneous risperidone formulations represent important additions to the antipsychotic armamentarium, offering alternatives that may improve adherence and outcomes for patients with serious mental illnesses.