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Articles

Safety in Lactation: Antagonists for central and respiratory depression

21 September 2020Naloxone is indicated for the treatment opioid-induced respiratory depression. If the clinical situation warrants an intervention to the breastfeeding mother, treatment should not be withheld.

What naloxone doses should be used in adults to urgently reverse the effects of opioids?

19 December 2019The opioid antagonist, naloxone, is a highly effective antidote the use of which is potentially life-saving. The drug has a role in a wide range…

In use product safety assessment report: naloxone products for emergency opiate reversal in non-medical settings

17 March 2016A UKMi Product Safety assessment on naloxone products for emergency opiate reversal in non-medical settings; in-use medication safety considerations resultant from the product presentation or…
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Lactation Safety Information

Yes
Low levels anticipated in milk due to the drug's properties
No published evidence of safety
24 September 2020

New Medicines

Narcan (US)Opioid overdose reversal - intranasal formulation

Information

Narcan (US)
New formulation
Adapt Pharma
Adapt Pharma

Development and Regulatory status

Discontinued
Discontinued
Launched
Nov 19Not listed in company pipeline, although other devices containing naloxone are in registrational trials (AP004 prefilled syringe & AP003 multidose nasal spray). No plans for EU development of Narcan discussed in latest quarterly report; assume the filing was withdrawn and there are no current plans for an EU licence [12,13].
Feb 17Was launched in US in Feb 16 [11].
Feb 17Adapt Pharma announce submission of MA application to EMA [10].
Nov 15Approved in US [9].
Sep 15Adapt Pharma announce FDA have accepted NDA for naloxone nasal spray [8].
Jul 15Adapt Pharma Limited (Lightlake´s partner) has submitted a NDA to the US FDA for Narcan® (naloxone) Nasal Spray. Narcan® Nasal Spray has been granted Fast Track Designation by the FDA [6].
Jun 15Lightlake commence rolling submission of a New Drug Application (NDA) to FDA for intranasal naloxone [5].
Mar 15Lightlake pipeline indicates the product to be in PIII development for opioid abuse in the US [4].
Feb 15Awarded fast track status by the US FDA [4].
Dec 14Lightlake Therapeutics entered into license agreement with Adapt Pharma (an Ireland-based pharmaceutical company). Adapt received a global license to develop and commercialise intranasal naloxone for opioid overdose reversal [3].
Jul 14Lightlake Therapeutics reported in August 2013 that it anticipates intranasal naloxone will be approved and brought to the US market within 12 - 18 months following submission of an NDA in 2014 [2].
Jul 14Lightlake announce it has received an additional commitment from the National Institute on Drug Abuse to fund a second study [1].
Jul 14Lightlake file an investigational new drug application (IND) in the US for its naloxone-based opioid overdose reversal nasal spray [1].
Jul 14PII in the US [2].

Category

An opioid receptor antagonist
In August 2014, there were 155,271 clients registered in England for treatment for opiate dependence, 7.7% of those completing treatment and not re-presenting [7].
Opioid overdose reversal - intranasal formulation
Intranasal

Trial or other data

Dec 13Interim pharmacokinetic data show naloxone nasal spray could be delivered into the blood stream at least as quickly as by intravenous injection [2].
Sep 13Lightlake Therapeutics, in collaboration with the Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA) of the National Institute on Drug Abuse (NIDA), initiated a PI study to establish a pharmacokinetic profile of intranasal naloxone. The trial expects to enrol approximately 14 healthy volunteers [2].

Evidence based evaluations

Cutaneous T-cell lymphoma (CTCL)-associated-pruritus - topical lotion

Information

New formulation
Elorac
Elorac

Development and Regulatory status

None
None
Phase III Clinical Trials
Yes
Yes

Category

Opioid mu receptor antagonist.
Annual UK incidence of cutaneous T-cell lymphoma is around 0.4 per 100,000 population (approximately 256 people per year in UK). Most people with CTCL are aged between 40 and 60 years old and it is twice more common in men than women [1]. Pruritus is the most frequent and the earliest symptom for most patients. However, it can vary in incidence and severity depending on the type of CTCL [2].
Cutaneous T-cell lymphoma (CTCL)-associated-pruritus - topical lotion
Topical