LATITUDE’s internal product development activities focus on addressing areas of unmet medical need through formulation. These efforts include taking known drugs and making significantly safer, more stable and/or easier-to-use versions that also comprise new intellectual property. Such re-formulations are designed to be eligible for the fast-track 505(b)(2) NDA, offering considerable time and cost savings for the licensor during FDA approval. LATITUDE’s currently available 505(b)(2) product candidates include:
Intra-V : a stable liquid, ready-to-use (RTU) intravenous formulation of the antibiotic vancomycin
Opti-V : a stable, liquid RTU, ophthalmic formulation of the antibiotic vancomycin
Rescue-G : a stable, liquid RTU injectable formulation of glucagon for hypoglycemia rescue
PumpaGon : a stable aqueous glucagon formulation suitable for a bihormonal insulin pump or artificial pancreas for prevention and treatment of hypoglycemia
PAC-E : a safer formulation of the anti-cancer drug paclitaxel (TAXOL®, ABRAXANE®) that shows significantly-reduced peripheral neuropathy, and which can be tolerated at a much higher dose than TAXOL®.
Nano-K : a stable, liquid, Cremophor®-free vitamin K formulation for preventing coagulation deficiencies in newborns or for treatment of dysmenorrhea (replacement for AquaMEPHYTON®).
Nano-A : a stable, polysorbate-free RTU amiodarone nanoemulsion for treating cardiac arrhythmias (replacement for Nexterone®)
24H Tramadol : a 24 hr release tablet for tramadol with proven in vitro release profile equivalent to Ultram® and Ryzolt®.
LATITUDE has also applied its formulation expertise to develop novel formulations of known drugs in new dosage formats:
- Diazepam (benzodiazepine for seizure rescue) for subcutaneous/intramuscular injection
- Celecoxib (NSAID COX-2 inhibitor) for intravenous injection
- Diclofenac (NSAID) for intravenous injection
- Insulin in an extended-release depot
- Progesterone for intravenous injection
For further information on these Licensing Opportunities, click here.