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Articles

Safety in Lactation: Antipsychotics

22 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Oral and non-depot antipsychotics with less…

Drug-induced hypersalivation – what treatment options are available?

1 August 2018This Medicines Q&A summarises published studies or case reports concerning the pharmacological treatment of drug-induced hypersalivation (drooling or sialorrhoea), particularly hypersalivation caused by clozapine. Update…
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Medicine Compliance Aid Stability

genericAurobindo

Aurobindo
generic
Tablets 50mg, 100mg, 200mg, 400mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from moisture
Hygroscopic protect from moisture. Maximum of 7 days in MCA
1 October 2015

SolianSanofi

Sanofi
Solian
Tablets 50mg, 100mg, 200mg, 400mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from moisture
Hygroscopic protect from moisture. Maximum of 7 days in MCA
1 October 2015

Lactation Safety Information

Quetiapine, Haloperidol
Very limited published evidence of safety
Moderate amounts in breast milk
Monitor infant for sedation, poor feeding, behavioural effects, extrapyramidal symptoms, and developmental milestones
9 November 2018

New Medicines

BarhemsysPost-operative nausea & vomiting (PONV) - first-line

Information

Barhemsys
New formulation
Acacia Pharma
Acacia Pharma

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Launched
Sep 21Marketing Authorisation Application (MAA) for Barhemsys has been submitted, validated and is now under formal review in major European markets and Acacia is working to progress international licensing agreements ahead of anticipated European approval in 2022. Presumed filed with the EMA; possibly also with the MHRA [17].
Aug 20In its interim results report, Acacia announces that it is now focused solely on achieving a successful commercial launch of Barhemsys and Byfavo (remimazolam) in 2H 2020 in the US; do not expect any EU developments in the immediate future [16].
Aug 20Launched in US for post-operative nausea and vomiting. The approval covers the treatment of PONV in adults who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis and the prevention of PONV, either alone or in combination with an antiemetic of a different class [15].
Feb 20Approved in US [14].
Sep 19FDA accepts the resubmitted NDA for amisulpride injection (Barhemsys), and has set a Prescription Drug User Fee Act (PDUFA) goal date of 26 Feb 20 [13].
Jul 19Acacia Pharma announce it had successful type A meeting with the US FDA relating to the new drug application. Acacia Pharma agreed with the US FDA to resubmit the NDA, designating a new supplier [13].
May 19FDA issues a second Complete Response Letter due to deficiencies at the contract manufacturer of amisulpride [12]
Nov 18Acacia Pharma resubmits the NDA for amisulpride to the US FDA. Additionally, Acacia Pharma contract manufacturer submits a CAPA to the US FDA, addressing the outstanding deficiency at its facility [11].
Oct 18FDA issues a Complete Response Letter due to deficiencies reported during a pre-approval FDA inspection of the contract manufacturer of amisulpride. The purity or stability of the active ingredient was deemed adequate, as were the manufacturing process and quality of the finished product. At this time, the FDA did not report concerns on any of the clinical or non-clinical data in the application [11].
Jan 18Filed in the US [10].
Nov 17Acacia Pharma intends to out-license amisulpride products APD403 and APD421, once it has conducted sufficient clinical development [10].
Nov 17No filings reported by Acacia [9].
Aug 16The company plan to seek approval for the treatment and prophylaxis of PONV alone and in combination [8]
Oct 15NCT02337062 due to complete [4]
Sep 15Acacia announces it is also studying amisulpiride in combination with other antiemetics as it positions itself for an FDA filing in H2 2016 [5].
Sep 13APD421 comprises an intravenous formulation of the marketed dopamine D2 /D3 antagonist amisulpride, for the completely new, patent-protected, use of management of PONV [1]

Category

Dopamine D2/ D3 receptor antagonists
PONV occurs in approximately 30% of all surgical patients, and in 70% of high risk patients. PONV is typically managed using a multimodal prophylactic approach including use of antiemetics in moderate to high risk patients. Despite routine use of prophylactic antiemetics, up to 40% of patients fail to respond, leading to increased health care costs (through prolonged discharge times or readmission) and reduced patient satisfaction.
Post-operative nausea & vomiting (PONV) - first-line
Intravenous

Trial or other data

Sep 21Company is planning to initiate the Phase 4 PROMPT study, which is designed to gather real world evidence on the benefits of using Barhemsys [17].
Aug 16Company report positive results from a pivotal PIII study (NCT02449291) investigating BAREMSIS™ (formerly APD421) for the treatment of established PONV in 568 subjects. BAREMSIS, in both standard and high dose, significantly improved the complete response rate (no recurrence of vomiting or requirement for further antiemetic rescue in the 24-hour period after treatment) vs placebo (p<0.025) [8].
Jan 16Acacia announces results from NCT02337062 (n=1204); complete response rate significantly improved by amisulpride when added on top of a standard antiemetic compared to placebo and a standard antiemetic (57.7% vs 46.6%, p=0.0002). All secondary efficacy endpoints, including the rate of vomiting, nausea and use of rescue medication, were also met [7]
Sep 15Acacia start a PIII RCT to compare efficacy of APD421 10mg & 5mg against placebo for treatment of patients feeling sick or being sick after an operation, who have not previously been given treatment for the condition [6].
Feb 15PIII trial initiated to assess the efficacy of amisulpride, in combination with a standard anti-emetic, in patients with PONV (NCT02337062). Complete response defined as protection from PONV, at 24 hours, is the primary endpoint of the trial. The randomised, double-blind trial is expected to enrol approximately 100 patients in the US, France and Germany [3]
Oct 14Acacia announce positive PIII data. Two double-blind, placebo controlled, PIII studies (conducted in 19 major centres in the US, France and Germany) recruited a total of 689 surgical patients with two or more of the four validated Apfel risk factors for PONV, of whom 626 were evaluable per protocol. APD421 was significantly superior to placebo (p=0.005), giving a relative risk reduction (RRR) of 19.4% in the incidence of PONV. There was no significant difference in the rate of adverse events between APD421 and placebo. Detailed data from these studies will be presented at an upcoming scientific meeting [2].
Sep 13Initiation of two pivotal PIII studies in 19 major centres in France, Germany and the USA to evaluate APD421 in 680 surgical pts at moderate-high risk of suffering PONV. The optimal dose of APD421 will be compared against placebo, the primary endpoint being no vomiting or retching and no requirement for anti-emetic rescue medication in the first 24 hours after surgery. The incidence and severity of nausea is also being studied. Studies are expected to complete in the first quarter of 2014. [1]