Safety in Lactation: Corticosteroids

9 November 2020There is very limited information on the use of corticosteroids during breastfeeding, although they are likely to be present in milk. Avoid prolonged high dose…

Safety in Lactation: Drugs used in nasal allergy

27 October 2020Drugs used for nasal allergy have limited systemic absorption in the mother, and pose negligible risk to a breastfed infant. There is no published evidence…

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…

Safety in Lactation: Topical corticosteroids

23 September 2020Topical corticosteroids are considered to pose a negligible risk to a breastfeeding infant as long as precautions are taken to avoid direct contact of the…

Which commonly used nebuliser solutions are compatible?

27 February 2020Mixing of nebuliser solutions should only be undertaken in the best interests of the patient and only by a person competent and willing to do…
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Lactation Safety Information


No published evidence of safety
Low levels anticipated in milk due to the drug’s properties
17 September 2020

For intranasal use

For intranasal use
There are no additional risks when used in combination in intranasal preparations containing azelastine
17 September 2020

For topical use

For topical use
High potency
17 September 2020

New Medicines

XhanceNasal polyposis


New formulation

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials

H1 18: Optinose intends to explore strategic collaboration opportunities in Europe and the rest of the world in order to maximize the commercial potential and the availability of XHANCE [6].

Apr 18: Launched in the US [5]

Sep 17: US FDA approved for the treatment of nasal polyps in adults. The company annouced plans to launch in the US in Q2 2018[2]

Jan 17: US FDA accepted for review for the treatment of nasal polyposis [2].

Nov 16: OptiNose filed an NDA for based on the results of the pIII NAVIGATE 1, NAVIGATE 2, EXHANCE-3; EXHANCE-12 and a PI bioavailability study [2].


Fluticasone propionate - intranasal corticosteroid delivered via a breath-activated device. For twice daily use.
The population prevalence of nasal polyps is reported as 2-4%. The male to female ratio has been reported at approximately 2:1
Nasal polyposis

Trial or other data

Oct 15: International NAVIGATE trial programme reported positive results from two double-blind RCT´s (N=323 pts per trial, including pts from the UK); NAVIGATE I (NCT01622569) and NAVIGATE II (EudraCT2011-004887-31, NCT01624662). Pts with bilateral nasal polyps were given intranasal fluticasone 100, 200 or 400µg, delivered by a bidirectional intranasal delivery device or placebo. In NAVIGATE I, intranasal fluticasone propionate resulted in significant reductions in nasal congestion or obstruction symptoms (P<0.001) as rated by patients and in total polyp grade (P<0.001) measured endoscopically. Fluticasone treated pts showed significant improvements in core disease symptoms such as nasal drainage, pain and pressure and loss of smell. In NAVIGATE II treatment with intranasal fluticasone led to reduction of nasal congestion/obstruction (-0.59, -0.68, and -0.62, respectively , P<0.001 vs placebo) and endoscopically measured total polyp grade (-1.31, -1.22, and -1.41, P < 0.001 vs placebo ). The most common adverse events were epistaxis and nasal mucosal disorder. [2-4]

Oct 15, Optinose completed 12 month, PIII EXHANCE-12 trial (N=223, NCT01623310) of 400μg intranasal fluticasone propionate given twice daily using a proprietary bi-directional device in pts with chronic sinusitis with or without polyps. Treatment with intranasal fluticasone propionate resulted in improvement in Sinonasal Outcomes Test (22-item) with mean improvement of 19.3 points, and on endoscopically assessed scores for change in local signs of disease, including nasal oedema. Most pts (72%) reported their symptoms being “much” or “very much” improved.[2-4]

Mar 15: Open-label, 3 month, PIII trial, EXHANCE-3 (N=706) completed in pts with chronic sinusitis with or without polyps (NCT01623323). Treatment with fluticasone propionate exhalation delivery system (FLU-EDS) showed complete resolution in 33.3% of pts with chronic rhinosinusitis with nasal polyps (CRSwNP) and 54.8% of pts with chronic rhinosinusitis without nasal polyps (CRSsNP). Improvement in Sino-Nasal Outcome Test - 22 scores were observed in CRSwNP (-23.7) and CRSsNP (-24.4). The most common adverse events were epistaxis and nasal mucosal disorder. [2-4]