Locked out! A new integrated device can help with patient adherence

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Joachim Koerner, director e-Device, R&D Prescription Division, Aptar Pharma, discusses intranasal drug delivery and how an integrated electronic lockout device can assist with patient adherence and help prevent drug misuse.

Intranasal drug delivery has been a popular option for many therapeutics over the years. Not only does it offer an easy route of administration, it is also convenient for patients, meaning adherence is usually less of a concern.

Delivering a therapeutic product via the nasal passage is non-invasive and essentially pain-free, thereby affording manufacturers the option to create a product fit for all patients, including seniors and paediatrics.1

Easily accessible route

The nasal cavity has an abundance of blood vessels within the mucosa.2 This facilitates drug adsorption as it increases the surface area available and has been reported as nearly equivalent in absorption rates to intravenous injections in certain instances.2

Administering drugs through the nose means that the issue of degradation within the gastrointestinal system is avoided, ensuring that more active product is systemically delivered, benefitting the patient. Moreover, the nose offers a route to the brain through the olfactory nerves, offering the potential to bypass the difficult to transverse blood–brain-barrier.

However, what needs to be considered if the drugs to be administered can be addictive, such as opioids? How can the safety of patients be ensured?

The issue with opioids

Opioids are a class of drugs that are commonly used for pain relief as they are strong and effective for this purpose. However, as they can also give a sense of euphoria when taken, an unwanted by-product of using these substances can be addiction and overdose (accidental or intentional).3

Rising rates of opioid abuse is a serious issue4,5 affecting patients both in Europe and the US. Some regulatory bodies are looking at the various ways in which they can reduce the incidences of addiction and misuse of these powerful drugs.6,7

A potentially beneficial way to manage patient adherence and prevent misuse of a therapy is to control the delivery via the mechanism of the device. It is this aspect that has been addressed in a novel device available from Aptar Pharma.

Locked out!

The e-Lockout is an integrated electronic nasal lockout device that features a lock-out mechanism, limiting the number of doses available within a 24-hour period.8 As such, patients can only use the device at specified intervals.

Further safety features include keeping track of the priming strokes, number of doses remaining inside and if the system is locked or ready-for-use, which is shown on an electronic display.

When the device locks itself, the display starts a visual countdown to let the patient know when it will unlock. Furthermore, the e-Lockout features a child-resistant cap, as a further safety measure.

Mark of approval

Earlier this year, the European Medicines Agency (EMA) approved the e-Lockout technology for a new version of Instanyl — a nasal spray used to treat breakthrough pain in adult cancer patients from Takeda. This new packaged product, Instanyl DoseGuard, will be launched in Europe, where the device is manufactured, and will be available in various multidose strengths.

This approval follows a multi-year development process between Aptar Pharma and Takeda, and represents the first fully integrated electronic nasal drug delivery device with time interval properties that has achieved regulatory approval in the EU or US.

References:

  1. Surber, C., et al., (eds): Topical Applications and the Mucosa. Curr. Probl. Dermatol., Basel, Karger, 2011;40:20–35. https://www.karger.com/ProdukteDB/Katalogteile/isbn3_8055/_96/_15/CUPDE40_04.pdf
  2. Ghori, M.U., et al., American Journal of Pharmacological Sciences, 2015;3(5):110–119. http://pubs.sciepub.com/ajps/3/5/2/
  3. https://www.drugabuse.gov/drugs-abuse/opioids
  4. https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-016-0909-3
  5. https://www.hhs.gov/opioids/about-the-epidemic/index.html
  6. http://www.emcdda.europa.eu/topics/pods/preventing-diversion-of-opioid-substitution-treatment
  7. https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm484714.htm
  8. https://pharma.aptar.com/en-us/dispensing-solutions/e-lockout.html