NexACT, a clinically validated multi-route drug delivery technology, utilizes patented highly effective, novel excipients or "penetration enhancers" to dramatically improve absorption and bioavailability of drugs. Varying the concentration of the enhancer allows for local or systemic delivery of drug, as desired.
The NexACT® technology allows:
- Topical/transdermal delivery of drugs (even proteins),
- Subcutaneous delivery of drugs in a depot-like fashion with improved bioavailability, and
- Oral delivery of poorly permeable/soluble compounds including compounds belonging to BCS 2 to 4 categories.
Our most advanced enhancer- "DDAIP HCl", is currently in use in formulations containing from small molecule to proteins, antibodies and RNAi therapeutics, and has been clinically evaluated in close to 5,000 subjects and over 150 pharm/tox studies.
NexACT utilizes biodegradable excipients, that when incorporated into drug formulations, will help overcome the body's natural barrier properties and enable rapid penetration of high concentrations of active drug directly through the skin and major biological membranes, resulting in more effective therapies. Future applications of the NexACT technology will be driven primarily by in-house development strategy and through out-licensing to pharmaceutical and biotechnology companies worldwide.
NexMed has incorporated the NexACT technology in a number of therapies indicated for a wide range of indications and across different classes of drugs. The products include:
Sexual Dysfunction:
Vitaros® (topical, alprostadil) for erectile dysfunction (NDA filed in the US and NDS filed in Canada)
Femprox® (topical, alprostadil) for female sexual arousal disorder (Phase 2 trials successfully completed in U.S., Phase 3 trials successfully completed in China),
Oncology:
PrevOncoTM (oral, lansoprazole) for hepatocellular carcinoma (IND accepted Phase 2/3)
Paclitaxel (topical, Taxol) for squamous carcinoma oral cancer (Pre-IND)
Nupen™ (topical filgrastim (Neupogen®)) for post-chemotherapy recovery of neutrophil counts (IND filed)
Fluorouracil (topical 5-FU) for actinic keratosis (Pre-IND)
Rituximab (sub-Q and topical, Rituxan®) for non-Hodgkin's lymphoma (Pre-IND)
Autoimmune:
RayVa™ (topical) for Raynaud's syndrome secondary to scleroderma (IND to be filed, Phase 2/3)
Anti-inflammatory:
PsoriaVa™ (topical, calcipotriene and betamethasone) for psoriasis (Pre-IND)
Pain:
Lidocaine (topical) (Pre-IND)
Antifungal:
MycoVa™ for onychomycosis (Phase 3 trials completed)
Metabolic Disease:
Insulin (sub-Q) for diabetes (Pre-IND)
Wound Healing:
Alprostadil (topical) (pre-IND)
Cosmeceutical:
Collagen DDAIP (Cosmetic) for anti-aging (clinical proof-of-concept)
The NexACT® clinically validated Multi-route drug delivery system represents an important breakthrough in improving the delivery of compounds currently administered via alternate routes by improving bioavailability and penetration. The NexACT® technology may allow conversion from IV delivery, thereby allowing patient self-administration and, potentially, Part D Reimbursement. The patented technology utilizes the same proven ingredients as in our transdermal formulations, DDAIP HCl. Varying concentrations of the active excipient in NexACT® will lead to formulations that slowly release or enhance delivery of the active drug into systemic circulation.
Results from a United States Pharmacopeia Preservative Efficacy Test (USP PET) qualified NexACT® as an anti-microbial preservative. The results show that NexACT® was effective in killing more than 23 strains of bacteria, fungus and mold, well beyond the requirements for passing the USP PET. These results are supported by the Company's prior, long-term stability and microbiology data, generated from its clinical batches of Vitaros®
The NexACT® skin penetration enhancer molecules are alkyl N, N-dimethylaminoacetates (esters of fatty alcohols and amino acids) and N, N-dimethylalkanol esters of alkanoic acids (esters of fatty acids and amino alcohols). Chemically, they are similar to the structure of the two building blocks of the human anatomy, namely proteins and lipids. In principle, the proteins and the lipids are composed of amino acids or alcohols and fatty acids, respectively. Therefore, the NexACT® enhancers are structurally similar and biologically compatible.
The NexACT® permeation enhancer molecules are designed to be non-toxic and readily metabolized by the body. A battery of more than 100 acute, sub-acute, and chronic toxicological and pharmacological studies in numerous animal species using different routes of administration have been completed on our most advanced enhancer, NexACT. Results from these preclinical studies, and the more than 5,000 clinical subjects evaluated, strongly support the safety of NexACT®.
