Nasal Spray Delivery Technology

What is it?

Nasal sprays are a needleless, reliable drug delivery system that can be a highly effective means of delivering a variety of medications, ranging from medicines to treat migraine to naloxone, a life-saving drug agent used to treat opioid overdose.

The architecture of the human nasal cavity limits the amount of liquid that can be effectively delivered in a spray to about 2-3 drops per nostril. This small volume means that nasal spray delivery technology can be only used for very potent medicines, where a full dose can be delivered in 2-3 drops. 

There are other factors determining the effectiveness of a nasal spray, including how rapidly the medicine reaches the bloodstream (from the nose), which is partly controlled by the size of the droplet and the shape of the spray, also known as plume geometry.

Why is it Effective?

For addiction and overdose medicines, the fundamental advantages of using nasal spray technology include the following.

  • Addiction: ease of use, portability, rapid uptake (best for symptom-driven approach), more targeted
  • Overdose: ease of use (no needles), portability, rapid uptake

In addition to ease of use and portability, nasal spray technology can deliver medicines to the bloodstream as quickly and effectively as an injection. These properties make nasal sprays especially useful when quickly reaching high blood levels is absolutely necessary, especially in medical emergencies such as opioid overdoses or for as-needed dosing to ensure the maximal amount of medicine is present to block the surge of endorphins. 

Because medications delivered in a nasal spray are absorbed through blood vessels in the nose, a patient does not have to be breathing for a nasal spray to be effective. This is critical in an opioid overdose, where a victim may have an extremely low respiratory rate or in many instances, not breathing at all.

We have licensed Intravail®, a proprietary absorption enhancer from Aegis Therapeutics (now a part of Neurelis), in order to make our nasal spray product candidates even more effective. This absorption enhancer dramatically reduces the time it takes to achieve high blood levels in some of our pipeline products.

Current Nasal Spray Programs and Candidates

Opiant developed the NARCAN® Nasal Spray. This product, licensed to Adapt (now a part of Emergent BioSolutions) in 2014, was FDA approved in late 2015. In just over three years, NARCAN® Nasal Spray has become the most widely used naloxone product in the United States.

We are also developing OPNT003, a nalmefene nasal spray for the treatment of suspected or confirmed opioid overdose. Nalmefene, an opioid antagonist previously FDA approved as an injection, is more potent and longer-acting than naloxone. This product candidate is being developed in response to the dramatic rise in fatalities due to high potency ‘synthetic’ opioids such as fentanyl, where a more potent, longer-lasting opioid antagonist may increase the probability of a successful rescue.

We are developing OPNT002, a naltrexone nasal spray for the treatment of Alcohol Use Disorder (AUD).

Naltrexone is an opioid antagonist, approved for the treatment of AUD as both a pill and a monthly injection. By using a nasal spray and asking our patients to take this when they feel the need to drink (“on-demand dosing”), the rapid delivery of high naltrexone concentrations can reduce the urge to drink, and therefore reduce drinking. Opiant continues to advance both clinical programs based on prior positive results.  We expect to conduct a pivotal PK study with nasal nalmefene in 2019, with a potential NDA filing by the end of 2020.  For AUD, we plan to initiate a Phase 2 study in late 2019.

Opiant continues to advance both clinical programs based on prior positive results.  We expect to conduct a pivotal PK study with nasal nalmefene in 2019, with a potential NDA filing by the end of 2020.  For AUD, we plan to initiate a Phase 2 study in late 2019.

For more information about our clinical pipeline products using nasal spray technology

Please refer to the following pages regarding nalmefene nasal spray for opioid overdose and naltrexone nasal spray for AUD.