GIVING PEOPLE THE CONFIDENCE TO DEFINE THEIR NEU NORMAL
At Neurelis, we know what empowerment can mean for people. That’s why we are dedicated to innovation that enables people to gain greater control over their journeys, so they can define their neu normal.
NEURELIS PIPELINE
Neurelis’ mission is to build a leading neuroscience company that advances the care of people suffering from neurological conditions. To do so, Neurelis is developing multiple wholly-owned product candidates for underserved acute neurological conditions. Product candidates include NRL-1004 (acute agitation), which utilizes our proprietary Intravail® drug delivery technology. In addition, Neurelis is developing NRL-1049, a new chemical entity for the treatment of cerebral cavernous malformations. If approved, NRL-1049 could be the first FDA-approved treatment for patients with this condition. Neurelis has also partnered with select program product candidates that employ Intravail® technology, including TOSYMRA® (acute migraine), NEFFY™ (anaphylaxis), OPVEE® (opioid overdose), and OPNT002 (alcohol use disorder).
PRE-CLIN
OTHER
Phase
1
1
NRL-1049
NRL-1004
Phase
2
2
OPNT002
Phase
3
3
VALTOCO®
(diazepam nasal spray)
Ages 2 through 5
NDA
NEFFY™
FDA
Approved
Approved
VALTOCO®
(diazepam nasal spray)*
Ages 6 and older
TOSYMRA®
(sumatriptan nasal spray)
OPVEE®
(nalmefene nasal spray)
NEURELIS PROGRAMS
| NEURELIS PROGRAMS | DESCRIPTION | DISEASE STATE | STATUS | DETAILS |
|---|---|---|---|---|
| VALTOCO® (diazepam nasal spray)* | Diazepam Nasal Spray Ages 2 and older Click here for full prescribing and important safety information. | Episodes of Frequent Seizures |  FDA Approved | Details |
| Diazepam Nasal Spray Ages 2 through 5 | Episodes of Frequent Seizures |  Phase 3 | ||
| NRL-1004 | Noninvasive proprietary formulation | Acute Agitation Episodes |  Phase 1 | Details |
| NRL-1049 | Proprietary oral formulation | Cerebral Cavernous Malformations | Phase 1 | Details |
| OTHER | Noninvasive proprietary formulation | Epilepsy/Central Nervous System Disorders |  Pre-Clin |
*VALTOCO® is licensed outside the US in China, Hong Kong, Taiwan, Singapore, and Macau by China Medical System, and in Australia, Brunei, Cambodia, Myanmar, New Zealand, the Philippines, Thailand, and Vietnam by AculysPharma.
Select Partner Programs
| Select PARTNER PROGRAMS | DESCRIPTION | DISEASE STATE | STATUS | DETAILS |
|---|---|---|---|---|
| TOSYMRA® (sumatriptan nasal spray) | An FDA-approved sumatriptan nasal spray utilizing Intravail® technology commercialized by Tonix Pharmaceuticals for the acute treatment of migraine with or without aura in adults. Tosymra offers an alternative to oral therapies, as well as to Imitrex® (sumatriptan nasal spray). Tosymra has demonstrated faster tmax as well as increased bioavailability when compared to subcutaneous sumatriptan. | Acute Migraine | FDA Approved |
|
| OPVEE® (nalmefene nasal spray) | An FDA-approved nalmefene nasal spray utilizing Intravail® technology being commercialized by Indivior for the treatment of opioid overdose.OPVEE® nasal spray was shown to provide fast onset and long duration reversal of opioid-induced respiratory depression. | Opioid Overdose | FDA Approved |
|
| NEFFY™ (epinephrine nasal spray) | An intranasal formulation of low-dose epinephrine utilizing Intravail® technology, licensed to ARS Pharmaceuticals, Inc. For the emergency treatment of severe type I allergic reactions in children and adults who weigh 30 kilograms (66 pounds) or more. | Anaphylaxis |  NDA |
|
| OPNT002 | A naltrexone nasal spray product candidate being developed by Indivior for the treatment of alcohol use disorder (AUD). | Alcohol Use Disorder |  Phase 2 |
|