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Articles

Safety in Lactation: Drugs for obstructive airways disease

25 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Bronchodilators Most bronchodilators are considered to…
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Medicine Compliance Aid Stability

DaxasAstraZeneca UK Limited

AstraZeneca UK Limited
Daxas
Tablet f/c 250 micrograms, 500 micrograms
A2 · Amber 2No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
This medicinal product does not require any special storage conditions.
22 November 2022

Lactation Safety Information

Salbutamol/ Terbutaline inhaler
Phosphodiesterase type-4 inhibitor
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties although long half-life increases risk of accumulation in breastfed infant
Monitor for effects on infant’s weight or appetite
21 April 2017

New Medicines

Zoryve Plaque psoriasis mild to severe, in adults and adolescents - cream formulation

Information

Zoryve
New formulation - repurposed medicine
Arcutis Biotherapeutics
Arcutis Biotherapeutics

Development and Regulatory status

None
None
Launched
Jul 22Approved in the US to treat plaque psoriasis, including in skin folds (intertriginous areas), among patients 12 years of age and above. The label covers all stages of disease from mild to severe without any limitations on duration of use. After years of commercial preparation, Arcutis will launch the steroid-free Zoryve cream immediately at a wholesale acquisition cost of $825 per 60-g tube [5].
Jul 22FDA have a target action date of 29/7/22 to review the NDA for roflumilast cream for the treatment of mild-to-severe plaque psoriasis [4]
Oct 21Arcutis Biotherapeutics announced it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for roflumilast cream for the treatment of mild-to-severe plaque psoriasis [1].

Category

Roflumilast is a highly potent and selective inhibitor of phosphodiesterase type 4 (PDE4) formulated as a once-daily cream for chronic use across the body [1]
The prevalence of psoriasis is estimated to be around 1.3–2.2% in the UK. Psoriasis can occur at any age, although is uncommon in children (0.71%) and the majority of cases occur before 35 years. Plaque psoriasis is by far the most common form of the condition (about 90% of people with psoriasis) [3].
Plaque psoriasis mild to severe, in adults and adolescents - cream formulation
Topical

Trial or other data

Sep 22Results of DERMIS 1 and DERMIS 2 trials are published in JAMA. In studies (n=881), roflumilast provided a greater chance of investigators global assessment of success (clear or almost clear & ≥2 improvement on 0-4 scale severity score) vs. vehicle (42.4% vs. 6.1%, 37.5% vs 6.9% for DERMIS 1 and 2 respecitively, p<0.001 for both studies) [6].
Oct 21Filing in the US is supported by positive data from the pivotal PIII program. The DERMIS 1 and DERMIS 2 trials (NCT04211363; NCT04211389) were identical randomised, parallel, double-blind, placebo-controlled, multi-national, multi-centre studies to evaluate the safety and efficacy of roflumilast cream 0.3%. Roflumilast met its primary endpoint and had an ‘IGA Success’ rate of 42.4% vs placebo rate of 6.1%, and 37.5% vs a placebo rate of 6.9%, in DERMIS 1 and 2 respectively. Roflumilast cream 0.3% also demonstrated statistically significant improvements over placebo on key secondary endpoints, including on Intertriginous IGA (I-IGA) Success, Psoriasis Area Severity Index-75 (PASI-75), reductions in itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS), and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). In trials, roflumilast cream was generally well-tolerated with a favourable safety and tolerability profile [1,2].