scholarly journals Assessment of the safety and ease of use of the naloxone auto-injector for the reversal of opioid overdose

2015 ◽  
pp. 21 ◽  
Author(s):  
Mark Merlin ◽  
Navin Ariyaprakai ◽  
Faizan Arshad
Keyword(s):  
Ease Of Use ◽  
Opioid Overdose ◽  
Auto Injector

scholarly journals Prehospital Medication Administration: A Randomised Study Comparing Intranasal and Intravenous Routes

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Cian McDermott ◽  
Niamh C. Collins
Keyword(s):  
User Satisfaction ◽  
Controlled Trial ◽  
Hospital Setting ◽  
Medication Administration ◽  
Ease Of Use ◽  
Opioid Overdose ◽  
Randomised Study ◽  
The Difference ◽  
Randomised Controlled ◽  
Mean Time

Introduction. Opioid overdose is an ever-increasing problem globally. Recent studies have demonstrated that intranasal (IN) naloxone is a safe and effective alternative to traditional routes of naloxone administration for reversal of opioid overdose.Aims. This randomised controlled trial aimed to compare the time taken to deliver intranasal medication with that of intravenous (IV) medication by advanced paramedic trainees.Methods. 18 advanced paramedic trainees administered either an IN or IV medication to a mannequin model in a classroom-based setting. The time taken for medication delivery was compared. End-user satisfaction was assessed using a 5-point questionnaire regarding ease of use and safety for both routes.Results. The mean time taken for the IN and IV group was 87.1 seconds and 178.2 seconds respectively. The difference in mean time taken was 91.1 seconds (95% confidence interval 55.2 seconds to 126.9 seconds,P≤0.0001). 89% of advanced paramedic trainees reported that the IN route was easier and safer to use than the IV route.Conclusion. This study demonstrates that, amongst advanced paramedic trainees, the IN route of medication administration is significantly faster, better accepted and perceived to be safer than using the IV route. Thus, IN medication administration could be considered more frequently when administering emergency medications in a pre-hospital setting.

scholarly journals Efficacy and Safety of up to 2 Years of Treatment With TransCon hGH (Lonapegsomatropin) in Treatment-Naïve and Treatment-Experienced Children With Growth Hormone Deficiency

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A676-A676
Author(s):  
Aristides K Maniatis ◽  
Samuel J Casella ◽  
Ulhas M Nadgir ◽  
Paul Hofman ◽  
Paul Saenger ◽  
...  
Keyword(s):  
Safety Profile ◽  
Bone Age ◽  
Ease Of Use ◽  
Hormone Deficiency ◽  
Height Velocity ◽  
Weekly Dose ◽  
Open Label ◽  
Post Dose ◽  
Treatment Naïve ◽  
Auto Injector

Abstract Background: Once-weekly TransCon hGH (lonapegsomatropin) is an investigational long-acting prodrug of somatropin in development for GHD. In the pivotal 52-week phase 3 heiGHt trial, lonapegsomatropin demonstrated superior annualized height velocity (AHV) compared to the same weekly dose of daily somatropin in treatment-naïve children with GHD. In the 26-week fliGHt trial, switch from daily somatropin to lonapegsomatropin provided continued growth and maintained a good safety profile. Methods: Results are reported from heiGHt and fliGHt subjects who continued into the open-label long-term extension enliGHten trial (data cut: June 1st 2020). Subjects received either lonapegsomatropin (Group A; vial/syringe) or daily somatropin (Group B; pen device) in heiGHt, or lonapegsomatropin in fliGHt (Group C; vial/syringe). Upon entry into enliGHten, all subjects received lonapegsomatropin via vial/syringe, with subsequent switch to TransCon hGH Auto-Injector when available. Average IGF-1 was obtained on post-dose Day 5 (±1) in enliGHten. A by-visit ANCOVA model was used for numeric efficacy endpoints. Results: A total of 298 (98%) subjects continued into enliGHten. (A: n=103; B: n=55; C: n=140). The treatment difference in LS mean ∆ height SDS (A vs B) at the end of heiGHt (Week 52, 1.10 vs 0.96, P=0.015) was sustained through Week 104 (1.61 vs 1.49, P=0.158). For Group C, height SDS improved from −1.42 at fliGHt baseline to −0.69 at Week 78. AHV was within the expected range for 2nd year therapy. Among children who switched (B), an attenuation in the expected 2nd year decline of AHV suggested that lonapegsomatropin had an improved treatment effect relative to the previous daily somatropin. Mean (SD) average IGF-1 SDS remained stable and generally within the expected range for all groups (Week 104, A: 0.95 [1.22], B: 1.04 [1.25]; Week 78, C:1.81 [1.08]). An improvement in injection site tolerability was observed after switching to the TransCon hGH Auto-Injector; subjects and parents also indicated overall ease-of-use of the device (assessed by the Device Usability Questionnaire). With continued lonapegsomatropin treatment, the AE profile remained consistent with what was observed in the parent trials, with no new safety signals. Throughout enliGHten and the parent trials, non-neutralizing low-titer anti-hGH binding antibodies were detected post-dose in a total of 15 subjects (5.0%). Lab parameters were stable and generally remained within the normal range throughout the trials. As of the data cut, 2 subjects have achieved near adult height (AHV <2 cm/year over the last 9 months or bone age >14 [females] or >16 [males]) and thus have completed the trial. Conclusions: Children treated with lonapegsomatropin showed continued improvement of height SDS through their 2nd year of therapy. Lonapegsomatropin continued to demonstrate a safety profile comparable to that of daily somatropin therapy.

Comparison of adrenaline auto-injector devices: Ease of use and ability to recall use

2014 ◽  
Vol 25 (5) ◽  
pp. 462-467 ◽  
Author(s):  
M. N. Robinson ◽  
S. C. Dharmage ◽  
M. L. K. Tang
Keyword(s):  
Ease Of Use ◽  
Auto Injector

scholarly journals 3570 The Regulatory Landscape of Products to Treat Opioid Overdose

2019 ◽  
Vol 3 (s1) ◽  
pp. 58-59
Author(s):  
Pooja Singh ◽  
Kaylene Okada ◽  
Amelia Spinrad ◽  
Nancy Pire-Smerkanich ◽  
Eunjoo Pacifici
Keyword(s):  
United States ◽  
Phase I ◽  
Nasal Spray ◽  
The United States ◽  
Regulatory Framework ◽  
Opioid Antagonist ◽  
Opioid Overdose ◽  
Opioid Crisis ◽  
Pubmed Search ◽  
Auto Injector

OBJECTIVES/SPECIFIC AIMS: Since 1971, Naloxone has been the only FDA approved opioid antagonist indicated for use after opioid overdose. New formulations of Naloxone have been introduced into the market, including an injectable, auto-injector, and nasal spray. However, Naloxone is short-acting and as such often requires multiple doses and may induce severe withdrawal symptoms. This study examines the regulatory framework to understand the evolution of products indicated to treat opioid overdose and the landscape of therapies in development. Furthermore, this study examines how the Food and Drug Administration (FDA) and other government agencies have approached the opioid crisis. METHODS/STUDY POPULATION: A PubMed search of “naloxone AND opioid overdose” with the filter “humans” was conducted to understand Naloxone’s regulatory framework. The term “naloxone” was searched on the Drugs@FDA: Approved Drug Products database. Additionally, “nalmefene” was searched on ClinicalTrials.gov. To examine the opioid antagonist market landscape, a PubMed search of “opioid antagonist AND opioid overdose” with the filters “humans” and “clinical trial,” and a ClinicalTrials.gov search of “opioid antagonist and opioid overdose,” were conducted. Government agency reports were reviewed and cataloged. RESULTS/ANTICIPATED RESULTS: Preliminary findings suggest a lack of innovation in the development of novel opioid antagonists. Most literature review findings focused on already-marketed Naloxone products, including the original injectable approved in 1971, the 2014 Evzio Auto-Injector, and the 2015 Narcan Nasal Spray (Figure 1). For example, there were 14 results yielded from the FDA approvals database, but none of these results represented a new opioid antagonist molecule. A longer-acting opioid antagonist, Nalmefene injectable, was approved in 1995 but has since been removed from the market due to low sales. Our initial ClinicalTrials.gov search using condition “opioid overdose” and other terms “opioid antagonist”,revealed no new studies being conducted on alternative opioid antagonist treatments for opioid overdose. Findings only focused on the distribution, co-dispensing, intervention, pharmacokinetics/pharmacodynamics (PK/PD) of Naloxone (Figure 2). However, a Google search yielded one new trial with an opioid antagonist by Opiant Pharmaceuticals, almost fifty years after FDA’s approval of Naloxone. A ClinicalTrials.gov search was then performed using the search term “nalmefene” to find whether Opiant Pharmaceuticals’ trial was in the ClinicalTrials.gov database. However, the Opiant trial is phase I, and as such does not require reporting on ClinicalTrials.gov. In 2017, the National Institutes of Health (NIH) launched an initiative for longer-acting opioid antagonist formulations. In 2018, Opiant Pharmaceuticals announced positive phase I results for intranasal Nalmefene. The potential return of Nalmefene in intranasal form may play a significant role in reducing overdoses, especially in cases where a longer-acting opioid antagonist is necessary. Opiant Pharmaceuticals’ trial commenced after the NIH announced their initiative; furthermore, the NIH’s National Institute on Drug Abuse granted the company $7.4 million to further the investigation of this drug. We will continue to research drugs that have previously been studied for the indication of treating opioid overdose in the United States and abroad and catalog them. DISCUSSION/SIGNIFICANCE OF IMPACT: The abuse and misuse of opioids in the United States has caused an epidemic accounting for over 115 opioid-overdose deaths each day, devastating our nation, both socially and economically. The United States spends $78.5 billion annually to combat the misuse of these drugs. Due to the severity of the opioid crisis, efforts to better understand approved therapies and investigational products in development to treat opioid overdose will be of significance moving forward. This research can inform agencies who are developing strategies to reduce opioid overdoses and pharmaceutical product developers about the current opioid antagonist landscape.

P118 CONTENT VALIDITY OF THE SUBCUTANEOUS ADMINISTRATION ASSESSMENT QUESTIONNAIRE (SQAAQ) IN ADULT AND ADOLESCENT PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS

2020 ◽  
Vol 26 (Supplement_1) ◽  
pp. S43-S43
Author(s):  
April Naegeli ◽  
Theresa Hunter ◽  
Laure Delbecque ◽  
Hayley Karn ◽  
Anne Skalicky
Keyword(s):  
Ulcerative Colitis ◽  
Content Validity ◽  
Self Efficacy ◽  
Drug Product ◽  
Subcutaneous Administration ◽  
Ease Of Use ◽  
Response Options ◽  
Severe Ulcerative Colitis ◽  
Auto Injector ◽  
Assessment Questionnaire

Abstract Background Subcutaneous (SC) delivery of biologic therapies is typically self-administered via a prefilled syringe or an auto-injector. Auto-injector devices are designed to offer a more convenient and more consistent administration of the drug product. The Subcutaneous Administration Assessment Questionnaire (SQAAQ) is a novel, 12-item, self-administered questionnaire that assesses ease of use of SC delivery devices and patient confidence while using the device to administer an injection of drug. This study aimed to establish evidence of the content validity of the SQAAQ among patients with moderate to severe ulcerative colitis (UC). Methods A cross-sectional, US-based, qualitative study using a semi-structured discussion guide was conducted using online focus groups and one-on-one telephone interviews among adolescent (12–17 years (yrs)) and adult (18 yrs+) participants with diagnosis of moderate-to-severely active UC recruited from clinical sites and patient panels. Cognitive debriefing of the SQAAQ instructions, items, recall period, scoring algorithm, and response options was conducted to assess understanding and interpretation of the items. The SQAAQ instructs patients to evaluate the questions based on “to what extent do you agree that the device you just used has these features” on a 7-point Likert scale ranging from “strongly disagree” to “strongly agree”. Results Thirty-one patients (n=27, 87% focus group; n=4, 13% telephone) participated in an interview. The majority were female (n=23, 74%); non-Hispanic or Latino (n=28, 90%); and White (n=22, 71%). Twelve (39%) were ≥18 yrs; 8 (26%) were 15–17 yrs; and 11 (35%) were 12–14-yrs. Administration of current medication use included: 48% on intravenous, 36% on SC, and 16% on oral. Adult and adolescent participants found the SQAAQ to be relevant, straight-forward, and easy to understand. Participants described the questionnaire as being ‘clear’, ‘detailed’, and felt as if the questionnaire included all the necessary items. All participants described the response options as ‘good’ and that they were able to select a response from a range of options. None of the participants had suggestions for changes to the response options. The confirmed conceptual framework (see Figure) for the SQAAQ depicts the 12 item concepts within 4 domains: ease of use (n=6 items), injection convenience (n=3 items), injection self-efficacy (n=2 items), and perceived self-efficacy (n=3 items). Conclusion Patient feedback confirms content validity of the SQAAQ and provides strong evidence that the concepts included in the SQAAQ are important to and well-understood by adults and adolescents with UC.

Morphogenetic machines revealed: Microscopy of living cells in the embryo of the frog, Xenopus laevis

1993 ◽  
Vol 51 ◽  
pp. 172-173
Author(s):  
Ray Keller
Keyword(s):  
Image Processing ◽  
Fluorescent Dyes ◽  
Cell Movement ◽  
Living Cells ◽  
Ease Of Use ◽  
Low Light ◽  
Amphibian Embryo ◽  
Large Populations ◽  
Light Fluorescence ◽  
Video Image Processing

The amphibian embryo offers advantages of size, availability, and ease of use with both microsurgical and molecular methods in the analysis of fundamental developmental and cell biological problems. However, conventional wisdom holds that the opacity of this embryo limits the use of methods in optical microscopy to resolve the cell motility underlying the major shape-generating processes in early development.These difficulties have been circumvented by refining and adapting several methods. First, methods of explanting and culturing tissues were developed that expose the deep, nonepithelial cells, as well as the superficial epithelial cells, to the view of the microscope. Second, low angle epi-illumination with video image processing and recording was used to follow patterns of cell movement in large populations of cells. Lastly, cells were labeled with vital, fluorescent dyes, and their behavior recorded, using low-light, fluorescence microscopy and image processing. Using these methods, the details of the cellular protrusive activity that drives the powerful convergence (narrowing)

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