dm+d

423594000

Lactation Safety Information

Yes
Oxytocin
Likely to be degraded in infant's GI tract
Only negligible amounts in breast milk
16 September 2020

New Medicines

PabalPrevention of post-partum haemorrhage due to uterine atony following vaginal delivery - IM administration

Information

Pabal
Licence extension / variation
Ferring
Akebia

Development and Regulatory status

Launched
Launched
None
October 2019
Oct 19Licence change approved by the MHRA approving use of existing Pabal formulation for IM use for prevention of postpartum haemorrhage due to uterine atony following vaginal delivery [9,10].
Sep 19The intravenous formulation of Pabal was approved in EU using the mutual recognition procedure; assume this formulation is also being assessed using this process [7,8].
Feb 19Currently pre-registration in EU [6].

Category

Oxytocin receptor agonist. IM administration.
Studies quote an incidence of PPH of around 5-10%. Incidence of severe PPH (blood loss >1000 ml or life-threatening) is quoted as around 0.3-1.86% depending on definition, and with regional variation. The most common cause of PPH is uterine atony [1].
Prevention of post-partum haemorrhage due to uterine atony following vaginal delivery - IM administration
Intramuscular

Trial or other data

Jun 18Results of PIII CHAMPION (ACTRN12614000870651; EudraCT 2014-004445-26; CTRI/2016/05/006969 - www.ctri.nic.in/) study published in NEJM [5].
Feb 18Completion of CHAMPION trial announced. This compared the effectiveness and safety of Ferring’s heat-stable carbetocin versus the current standard of care, oxytocin, for preventing PPH after vaginal birth. Heat-stable carbetocin could address a significant limitation associated with oxytocin – the need for refrigeration during shipping and storage to prevent degradation in temperatures above 8°C [4].
Feb 17Another PIII study (CHAMPION; ACTRN12614000870651 - anzctr.org.au) is underway. This randomised, double-blind, active, controlled, multinational, multicentre, non-inferiority trial is using carbetocin room temperature stable (RTS) for prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally. Participating countries include UK, South America, Asia, Africa and Australia [2].
Feb 15PIII IMox study starts (NCT02216383). The trial will recruit 6285 women over 13 months, in four maternity units in the South-West of England to compare the effectiveness, side effects and cost of Syntocinon, Syntometrine and Carbetocin, for women having a vaginal birth. Women will be randomly allocated to receive one of these drugs. Primary outcome is requirement for additional uterotonic drugs from administration of prophylactic uterotonic agent to discharge from labour ward, within an expected average of 6 hours. The study is expected to complete Feb 17 [3].

Prader-Willi syndrome - hyperphagia and other linked symptoms (obsessive compulsive symptoms and anxiety)

Information

New formulation
Levo Therapeutics
Levo Therapeutics

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Oxytocin analogue with improved receptor binding profile
Prader-Willi syndrome is a complex genetic disorder characterised by hypotonia and developmental delay as an infant and obesity, learning disability and behavioural problems (especially relating to food) in adolescence and adulthood. Prevalence 1/15,000-1/30,000 (relatively common) [2].
Prader-Willi syndrome - hyperphagia and other linked symptoms (obsessive compulsive symptoms and anxiety)
Intranasal