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Articles

Safety in Lactation: Nicotine dependence

4 November 2020Cigarette smoking leads to both oral and inhalational exposure of breastfed infants to cigarette constituents, including nicotine, although no adverse effects due to ingestion of…
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Medicine Compliance Aid Stability

ChampixPfizer Ltd

Pfizer Ltd
Champix
Tablets f/c 500microgram, 1mg
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
No special storage conditions.
3 March 2015

Lactation Safety Information

Nicotine
Long half-life increases risk of accumulation in breastfed infants
No published evidence of safety
18 September 2020

New Medicines

Dry eye syndrome (DES)

Information

New formulation
Oyster Point Pharma
Oyster Point Pharma

Development and Regulatory status

None
None
Pre-registration (Filed)
Dec 20New Drug Application submitted to the FDA for varenicline nasal spray for the treatment of signs and symptoms of dry eye disease [5].
May 20The company announced plans to submit a New Drug Application (NDA) to the US FDA in H2 2020 with plans, if approved, to launch in Q4 2021.[3]

Category

Nicotinic receptor agonist - stimulates trigeminal parasympathetic pathway promoting natural tear film production and helping re-establish tear film homeostasis.[2]
Dry eye syndrome is estimated to affect between 5% and 33% of the adult population worldwide
Dry eye syndrome (DES)
Intranasal

Trial or other data

May 20PIII ONSET-2 trial (NCT04036292) in pts with dry eyes completes.In the 0.6 mg/ml dose cohort, the percentage of pts improving past 10 mm Schirmer’s score (a measure of tear film production) was 44% compared with 47% in the 1.2 mg/ml cohort and 26% with the control group. The most common side effect was transient and mild sneezing. There were otherwise no serious adverse events related to nasal administration.[3,4]
Jan 20PII randomised, double-blind MYSTIC trial evaluating the chronic safety and effectiveness of varenicline nasal spray on signs of dry eye disease (n=123, OPP-004; NCT03873246) completed. [2]
Oct 19PII/III open label, randomised, double-masked ONSET trial (n=101, OPP-002-01EXT; NCT03920215) that assessed the safety of varenicline nasal spray at six months and 12 months post treatment in the OPP-002 study completes.[2]
Sep 19PII randomised, open-label IMPERIAL trial evaluating the safety and efficacy of varenicline nasal spray on goblet cell and meibomian gland stimulation in patients with dry eye disease (n=21, OPP-005; NCT03688802) completed. [2]
Jul 19PIII multicentre, randomised, double-masked, vehicle-controlled ONSET-2 trial (N= 758, NCT04036292) initiated to evaluate the safety and efficacy of varenicline nasal spray for treatment of pts with dry eye disease. [2]
Sep 18PII double-blind, multicentre, parallel, prospective, randomised ONSET-1 trial that evaluated the safety and effectiveness of varenicline nasal spray vs. placebo on signs and symptoms of dry eye disease (DED) (OPP-002; NCT03636061) completes. The trial demonstrated statistically significant improvements in both the pre-specified primary sign endpoint and multiple pre-specified secondary symptom endpoints vs. placebo. [2]