The newsletter contains information about the FDA’s decision regarding roluperidone, a new medication proposed for treating negative symptoms in schizophrenia.
Additionally, it presents key points from a recent interview discussing pharmacologic treatment options for autism spectrum disorder (ASD) and a presentation on how to manage behavioral emergencies with newer options such as dexmedetomidine.
FDA Verdict on Roluperidone
On February 27, 2024, the FDA issued a complete response letter (CRL) regarding the new drug application (NDA) for roluperidone’s potential use in addressing negative symptoms of schizophrenia. This is an area demanding attention and exploration of options, as existing antipsychotics primarily concentrate on positive symptoms.
- What is roluperidone?
- Roluperidone is a compound with antagonist properties for 5-HT2A, sigma-2, and a1A-adrenergic receptors.
- It was specifically developed for the treatment of negative symptoms in schizophrenia.
- What was issued in the CRL?
- The FDA rejected roluperidone and asked for more efficacy and safety data.
- This was due to insufficient evidence of its effectiveness in treating negative symptoms, a lack of information on the use of roluperidone with other antipsychotics, and an inadequate number of subjects within the submitted safety database.
- What do we know about roluperidone’s efficacy?
- In a phase 2b randomized, double-blind, placebo-controlled study, roluperidone demonstrated statistical significance in improving negative symptoms.
- However, roluperidone 32 mg and 64 mg did not demonstrate a statistically significant change in the negative symptoms over 12 weeks, according to the Positive and Negative Syndrome Scale. Learn more here.
- Who would be the ideal candidates for roluperidone treatment?
- Roluperidone does not directly block dopaminergic receptors; thus, patients need to present stable positive symptoms and exhibit minimal agitation.
- What is needed from the pharmaceutical company for a successful NDA submission?
- Submit at least 1 additional positive, adequate, and well-controlled study.
- Provision of further data to demonstrate the safety and efficacy of roluperidone when coadministered with antipsychotics
- Evidence that the observed effect on negative symptoms with roluperidone treatment corresponds to a clinically significant change
- Demonstration of long-term safety
- Will roluperidone be available soon if found effective?
- Unlikely; the phase 3 clinical trial to examine the drug’s safety and effectiveness in treating schizophrenia is projected to last nearly 23 months.
- Responding to FDA’s concerns will postpone roluperidone’s potential market launch.
In conclusion, additional studies and data are imperative to affirm the safety and effectiveness of roluperidone. It remains crucial to identify a medication specifically designed to address negative symptoms, offering essential relief for patients.
The Role of Psychopharmacology in ASD With Christopher Keary, M.D.
In this interview, Dr. Christopher Keary reviews principles regarding the management of ASD. He begins by highlighting the importance of involving the family in therapy and proceeds to discuss management strategies for challenging symptoms associated with ASD, such as catatonia, anxiety, and sleep problems.
Interview highlights include the following:
- Freezing spells in pediatric patients with ASD should be considered highly important for diagnosis, as these are frequently seen in catatonia, particularly in this population.
- Buspirone has excellent tolerability among pediatric patients with ASD and should be considered for management of anxiety in this population—it is “a hero for its tolerability.”
- For patients with ASD who start taking antipsychotic medication, consider initiating metformin if there is an increase in their body mass index of 8% or more.
Learn more and earn 0.5 CME credits here.
The Psychopharmacology of Agitation: Managing Behavioral Emergencies
In this video lecture, Dr. Scott Zeller discusses the psychopharmacology of agitation and the management of behavioral emergencies. He explains how to distinguish between different mental diagnoses in agitated patients, such as delirium, dementia, and psychotic disorders, amongst others. He also discusses the various pharmacologic approaches for managing agitation, placing a significant emphasis on medication options, including lorazepam and dexmedetomidine.
The Role of Benzodiazepines and Dexmedetomidine in Managing Agitation
- Benzodiazepines are useful in managing agitation, especially when little is known about the patient.
- Benzodiazepines are benign and well-tolerated medications, especially compared with antipsychotics.
- Dexmedetomidine is a new available option for treating agitation.
- The sublingual form has a unique mechanism of action.
- It is effective for managing agitation in patients with schizophrenia and bipolar disorder.
Learn more and earn 1.25 CME credits here.
Quick Takes: Research, Digested
Efficacy of Memantine in Treating Trichotillomania and Skin-Picking Disorder
- Many patients suffering from trichotillomania and skin-picking disorder do not report them due to a lack of awareness, making it crucial for clinicians to actively screen for these conditions.
- A double-blind, placebo-controlled study found that patients with these disorders had a substantial response to memantine. The study showed a 60% response rate for the group on memantine, with even better responses observed in patients with severe levels of illness. Learn more.
Listen to or read the full volume and earn 0.5 CME credits here.
- Join our Silver or Gold membership program and start earning CMEs and SAs. Also, listen to all of our content through your favorite podcasting app. Click here.
References
- Minerva Neurosciences Inc. (2024, February 27). Minerva Neurosciences receives complete response letter from FDA for New Drug Application for roluperidone for the treatment of negative symptoms in patients with schizophrenia. https://ir.minervaneurosciences.com/news-releases/news-release-details/minerva-neurosciences-receives-complete-response-letter-fda-new
