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Safety in Lactation: Sedative and analgesic peri-operative drugs

25 September 2020Benzodiazepines are used for premedication and for conscious sedation during surgery. Following short–term therapy (1-2 doses) for these indications, it is considered that breastfeeding can…
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Lactation Safety Information

Caution
Lorazepam
Very limited published evidence of safety
Small amounts in breast milk
Monitor infant for drowsiness and/or poor feeding
14 March 2018

New Medicines

Agitation in bipolar disorder

Information

New formulation - repurposed medicine
BioXcel Therapeutics
BioXcel Therapeutics

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Pre-registration (Filed)
Apr 22Approved in US for treatment of mild, moderate or severe agitation in patients with schizophrenia or bipolar I or II disorder [10].
Oct 21EU filing now anticipated H1 22. BioCxel still plans to seek a collaborative partner in Europe [8].
May 21Company plans to file a Marketing Authorisation Application to the EMA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders in H2 2021 [7].
May 21US FDA accepts the NDA for dexemedetomidine sublingual film, for the acute treatment of agitation in patients with schizophrenia and bipolar disorders I and II. It assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 5, 2022. The submission was based on phase III trials SERENITY I and SERENITY II [6].
Nov 20Company is seeking regional partners for Japan and Europe to allow commercialisation outside the US [4].
Aug 20Bioxcel plans to file in the US Q1 21. No plans for filings in other countries announced [3].
Dec 18BioXcel announces that the US FDA granted fast track designation to BXCL 501 for acute treatment of agitation in schizophrenia, bipolar disorder and dementia [3].

Category

Selective alpha-2a receptor agonist in sublingual film presentation
Agitation is a common and difficult to manage symptom associated with a number of psychiatric conditions, including schizophrenia and bipolar disorder [1].
Agitation in bipolar disorder
Sublingual

Further information

Yes

Trial or other data

Feb 22SERENITY II RCT (n=380) found sublingual dexmedetomidine at dose of 180mcg or 120mcg reduced mild-moderate agitation vs. placebo at 2 hours after treatment (Positive & Negative Syndrome Scale-Excited Component total score of−10.4, −9.0 & −4.9, respectively; possible total score range, 5-35) [9].
Oct 21SERENITY I = NCT04268303; SERENITY II = NCT04276883 [5].
Jun 20In PIII trials SERENITY I and SERENITY II, BXCL501 met primary and secondary endpoints, with a statistically significant reduction in PEC score, and in both trials achieved over 80% response rate. The principal side effect was somnolence [2].
Jan 20Two PIII trials (SERENITY I in schizophrenia and SERENITY II in bipolar disorder) start, topline data expected mid 2020 [1].

Evidence based evaluations

Agitation in schizophrenia

Information

New formulation - repurposed medicine
BioXcel Therapeutics
BioXcel Therapeutics

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Approved (Licensed)
Apr 22Approved in US for treatment of mild, moderate or severe agitation in patients with schizophrenia or bipolar I or II disorder [9].
Oct 21EU filing now anticipated H1 22. BioCxel still plans to seek a collaborative partner in Europe [8].
May 21Company plans to file a Marketing Authorisation Application to the EMA for BXCL501 for the acute treatment of agitation associated with schizophrenia and bipolar disorders in H2 2021 [7].
May 21US FDA accepts the NDA for dexemedetomidine sublingual film, for the acute treatment of agitation in patients with schizophrenia and bipolar disorders I and II. It assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 5, 2022. The submission was based on phase III trials SERENITY I and SERENITY II [6].
Nov 20Company is seeking regional partners for Japan and Europe to allow commercialisation outside the US [4].
Aug 20Bioxcel plans to file in the US Q1 21. No plans for filings in other countries announced [3].
Dec 18BioXcel announces that the US FDA granted fast track designation to BXCL 501 for acute treatment of agitation in schizophrenia, bipolar disorder and dementia [3].

Category

Selective alpha-2a receptor agonist in sublingual film presentation
Agitation is a common and difficult to manage symptom associated with a number of psychiatric conditions, including schizophrenia and bipolar disorder [1].
Agitation in schizophrenia
Sublingual

Trial or other data

Oct 21SERENITY I = NCT04268303; SERENITY II = NCT04276883 [5].
Jun 20In PIII trials SERENITY I and SERENITY II, BXCL501 met primary and secondary endpoints, with a statistically significant reduction in PEC score, and in both trials achieved over 80% response rate. The principal side effect was somnolence [2].
Jan 20Two PIII trials (SERENITY I in schizophrenia and SERENITY II in bipolar disorder) start, topline data expected mid 2020 [1].

Evidence based evaluations