NLPClinical has targeted several products that utilize our novel delivery systems to commercialize and bring to market and is working with the FDA through the Investigational New Drug process.
FDA Emergency Use Authorization (“EUA”) Process.
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.
Under the FDA’s EUA process, NLP has submitted an application for a Covid-19 preventative and therapy to treat those with mild and moderate cases of Covid-19. The product is an Inhaled dry-powder Therapeutic called “NLPINHALED-CV”. The FDA has assigned Case No. ####. The therapy utilizes inhaled Sildenafil Citrate to create Nitrous Oxide (“NO”) in the lungs to kill the Covid virus where it enters the body. It will also enhance O2 levels in the blood. We intend to roll out Pre-Clinical Studies with several Doctors and Hospitals and continue to work with the FDA.
The inhaled CBD platform is an inhaled dry powder product used to enhance the mucous membrane in the lungs and create a barrier to viruses, including Covid-19 virus. We intend to submit this as a preventative with the FDA under the EUA process.
*Note – separate from the EUA process, a study in also being conducted on using our same Oral Capsule technology to increase the mucous membrane in woman’s vaginal cavity using CBD. The studies are focused on menopause and to prevent the transmission of HIV.
Standard FDA Applications (Non-EUA)
NLP intends to submit an FDA application for Inhaled Sildenafil for Erectile Dysfunction (“ED”). This would be a new FDA IND application. We are also looking to leverage companion ED products in the form of tablet generic Viagra.
NLP intends to submit an FDA application for Oral CBD capsules to target various ailments based upon our initial use cases in order to make claims. Through initial work with patients, our CBD capsules have been shown to improve a great many ailments. However, targeting sales for specific treatments requires one to go through the FDA application and approval process. Our capsules have been used by people to treat Ulcerated Colitis, Eczema, Parkinson’s and support Pain Therapy.
Non Regulated Products pipeline
Through NLP’s Ecommerce Platform, we offer specialty CBD-based products. Our leading Capsule Technology “NLPVCAPS-CBD” utilize full spectrum CBD which we feel has the best overall effectiveness for our customers over CBD isolate. Our specialty coated vegetable oral capsule technology delivers the CBD approximately 12” into the intestinal tract placing the CBD where is has the highest bioavailability.