Deck: Discussing ARS Pharmaceutical’s neffy®, a single-dose epinephrine nasal spray, with its contract development and manufacturing partner, Renaissance Lakewood, LLC.
Eric Kaneps is Vice President of Sales & Marketing at Renaissance Lakewood, a CDMO specializing in nasal sprays. In our conversation at CPHI Milan, Kaneps discussed, among other topics, Renaissance’s involvement in neffy, a single-dose epinephrine nasal spray designed to combat life-threatening, allergic emergencies including anaphylaxis in adults who weigh 30kg or more, who are at risk of have a history of serious allergic emergencies.
“[Neffy] is the first and only approved needleless epinephrinenasal spray,” said Kaneps. “Most allergy patients are familiar with the EpiPen, which is an auto-injector that they inject intotheir body. Neffy is a nasal spray that uses a unit dose nasal spray device that the patient can self-administer nasally without using a needle. So [it’s] really a game changer for people with food allergies, particularly, I think, for younger people with these food allergies, and ARS has recently submitted their pediatric indication for Type I allergic reactions in patients weighing between 15 to 30 kg.. So that should hopefully get approved soon as well.”
According to Kaneps, ARS faced many questions of efficiencygiven this new nasal delivery system versus a more traditional injectable delivery. For instance, the FDA requested additional data on repeat dose pharmacokinetic (PK)/ pharmacodynamic(PD) under nasal allergen challenge (NAC), which necessitated that ARS Pharmaceuticals, conduct additional clinical trials to show neffy was effective in those situations, which the trial confirmed.
Kaneps noted this was a bit of a coming-out-party for Renaissance, which typically operates as a “silent partner” with various drug manufacturers on nasal spray products. (Indeed, there were several products Renaissance has worked or is working on that Kaneps could not discuss with 24/7 Biopharma on the record.) However, for neffy specifically, the company felt that it should change its approach.
“I think this could be the product that educates Americans about the effectiveness of nasal sprays, as many people are familiarwith corticosteroid (for congestion) and naloxone nasal sprays(for the treatment of opioid overdose) but these are not productsyou see people carrying and speaking about over lunch,” said Kaneps. “Everyone knows someone that uses an epinephrine auto injector, so people are very interested in an alternative and have shown real excitement when they learn that neffy is now commercially available.
In this vein, for Kaneps, the success of neffy could lead to a broader understanding of the versatility and effectiveness of nasal sprays as a drug dosage form in the broader market. And while they’ve typically been paired with small molecules, there’s nothing stopping nasal sprays from delivering more complex biologics as well.
“Taking pills is the American way, right?” said Kaneps. “But I think we’re learning about other drug delivery platforms. I see growth in alternatives to oral solid dose drug delivery. Nasaldelivery is growing in popularity due to the ease of administration and the effectiveness of delivering drug to the nasal mucosa. We are also excited about biologics, I think there’s interest in nasal delivery, and there will be growth in the future. We’re evaluating if we should get into this space, because we’re currently working mostly with small molecules and some peptides … [but] if we can find ways to get those larger molecules into the nose and through the nasal membrane, however you want to deliver them, then I think there’ll be a lot of opportunity for growth.”
