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Articles

Providing patient information leaflets following COVID-19 treatment

31 March 2021Following treatment for COVID-19 with tocilizumab, sarilumab, or steroids, clinicians should provide suitable patient information leaflets at discharge

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…

What injections can be given orally or via enteral feeding tubes?

6 November 2020This updated Medicines Q&A is a quick reference summary to different types of enteral feeding tubes, in relation to medication issues. Not all enteral feeding…
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Medicine Compliance Aid Stability

genericAspire Pharma Ltd

Aspire Pharma Ltd
generic
Tablets 0.5mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from light
Protect from light.
3 April 2022

genericAspen

Aspen
generic
Tablets 2mg
A3 · Amber 3No stability data is available. There are theoretical concerns with use in CAs, which may be mitigated by risk minimisation.
Protect from light
Protect from light
3 April 2022

Lactation Safety Information

Oral / Parenteral

Oral / Parenteral
Prednisolone (oral), Hydrocortisone (parenteral)
No published evidence of safety
Used in infants >1 month
Doses up to 8mg daily unlikely to cause adverse effects in the infant
23 June 2020

Local injection

Local injection
No published evidence of safety
Lower systemic absorption compared to oral and parenteral therapy
Theoretical risk of milk production being reduced temporarily
23 June 2020

For use in the eye or ear

For use in the eye or ear
Yes
There are no additional risks when combination topical preparations containing antibiotics are used
No published evidence for use in breastfeeding
Limited systemic absorption in the mother, therefore negligible risk to the infant
7 June 2022

New Medicines

Ocular inflammation and pain post cataract surgery - sustained-release topical formulation

Information

New formulation
Sun Pharma
Sun Pharma

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Topical corticosteroid, using DuraSite® sustained delivery technology, comprising a patented, synthetic, bio-adhesive, polymer-based formulation designed to extend the residence time of a drug relative to conventional topical therapies.
Around 330,000 cataract operations are performed per year in England. Overall crude estimates suggests surgery incidence rates of approximately 530 per 100,000 population or 3,200 per 100,000 for those over 65 years old per year in recent years (2011 data). Incidence rates of post-cataract surgery inflammation range from 1.5% and 2% but does not take into account people with diabetes. This would equivalent to 4,590 to 6,600 cases of post-cataract surgery inflammation in England/year [1].
Ocular inflammation and pain post cataract surgery - sustained-release topical formulation
Topical

Evidence based evaluations

DextenzaOcular itching associated with allergic conjunctivitis - ophthalmic insert

Information

Dextenza
New formulation
Ocular Therapeutix
Ocular Therapeutix

Development and Regulatory status

None
None
Launched
Oct 21Dextenza approved by FDA to treat eye itching associated with allergic conjunctivitis [10].
Dec 20Filed in US for ocular itching associated with allergic conjunctivitis [9].
Sep 20 If the third PIII trial is successful the company plans to file for ocular itching associated with allergic conjunctivitis in the US. Top line data from this trial are due H1 2020 [7].
Dec 18Still listed as PIII on company pipeline but no reports of further development [6]
Apr 17Remains PIII in the US for chronic allergic conjunctivitis; has been filed with the FDA for treatment of post-surgical ocular pain [5].

Category

Sustained-release low dose formulation of dexamethasone; a preservative-free ophthalmic insert that is inserted in the lower lacrimal punctum and into the canaliculus.
Allergic conjunctivitis is the cause of around 15% of all eye problems presenting in general practice [1].
Ocular itching associated with allergic conjunctivitis - ophthalmic insert
Intravitreal

Trial or other data

Apr 20In PIII trial, DEXTENZA met all pre-specified primary endpoints with a statistically significant mean change in ocular itching from baseline (p<0.0001), on a subject-reported 5-point scale, at three time points on Day 8, 1 week after insertion of DEXTENZA [8].
Aug 19A third randomised, double-blind, placebo-controlled PIII trial to assess the efficacy and safety of Dextenza for the treatment of ocular itching associated with allergic conjunctivitis (NCT04050865) has started and intends to recruit 80 patients in the US. The trial is designed to assess the effect of Dextenza vs placebo on allergic reactions using a series of successive allergen challenges over a 30 day period. The primary efficacy endpoint is ocular itching following insertion of Dextenza at multiple time points during the 30 day period [7].
Jun 16Ocular Therapeutix reports that the PIII trial (NCT02988882) did not meet primary endpoint. The trial completed May 2016, and was designed to assess the effect of OTX-DP versus placebo on allergic reactions using four series of successive allergen challenges over a 30-day period. The primary endpoint of the trial was ocular itching at day 7 following insertion. The trial was initiated in November 2015 and enrolled 86 patients in the US [5].
Oct 15Ocular Therapeutix announces topline efficacy results from a PIII trial (NCT02445326). The primary endpoint of treatment of ocular itching associated with allergic conjunctivitis was successfully achieved (p<0.0001) at all three time points measured on day 7 post-insertion of the drug product. The difference in the scores for ocular itching between the DEXTENZA group and the placebo group was greater than 0.5 units at all time points on day 7 post-insertion and was greater than 1 unit at a majority of the time points on day 7 post-insertion. The DEXTENZA treatment group did not achieve the primary endpoint for conjunctival redness. Ocular Therapeutix notes the primary endpoint of conjunctival redness is typically an endpoint included in PIII trials for allergic conjunctivitis but has not been required for approval & many commercially available prescription medications for treatment of allergic conjunctivitis have an ocular itching indication only [4].
Apr 15A PIII trial of 240 pts showed significant absence of pain in the treatment group after several days in comparison to the placebo group. However, there was no statistically significant difference in the reduction of inflammation between pts who received the mediation vs. placebo. The trial did meet its expected endpoints regarding safety of the medication. The company are conducting a review of the data in order to better understand the results [3].
Nov 14Ocular Therapeutix announced top-line results from PII trial of OTX-DP in allergic conjunctivitis caused by any allergen. The prospective, multicentre, randomised, double-blinded study evaluated OTX-DP vs. a placebo vehicle control in 68 pts over 42 days. The primary endpoint was a measure of ocular itching and conjunctival redness at 14 days post-insertion on a five point scale. OTX-DP treated subjects presented statistically significant lower ocular itching and conjunctival redness scores compared with the placebo group on day 14 (-0.5 points vs. placebo) but did not, however, achieve a mean difference of 1.0 unit at the majority of time points [2].
Nov 14OTX-DP (a low dose formulation of dexamethasone loaded onto an inert hydrogel punctal plug) is a punctal plug designed to be placed in the canaliculus of the eye releasing dexamethasone slowly over 2 weeks. This period is followed by a 2 week taper, after which the plug starts to degrade and passes out of the nasolacrimal system without requiring assisted removal [2].

Evidence based evaluations

OtividexMénière's disease - intratympanic injection

Information

Otividex
New formulation
Otonomy
Otonomy

Development and Regulatory status

Discontinued
Discontinued
Discontinued
May 21Development discontinued based on a comprehensive analysis of the results from the PIII trial that failed to meet its primary endpoint [14].

Category

Glucocorticoid receptor agonist
Estimate prevalence in the UK is ~157 per 100,000 of the population. It can occur at any age but the peak incidence is 40-60 years [1].
Ménière's disease - intratympanic injection
Intratympanic

Trial or other data

Feb 21PIII study of OTO-104 (NCT03664674) fails to meet primary endpoints. 148 patients were randomised to receive a single intratympanic injection of a sustained-release formulation of the steroid dexamethasone or placebo. The primary endpoint assessed the number of vertigo days, as recorded in patient diaries, in month three. Otividex was no better than placebo for it´s primary endpoinbt (p=0.312). However, the per protocol p-value was 0.031 [13].