Injectable antipsychotic drug delivered by Captisol technology
that an intramuscular injection formulation of schizophrenia drug
Abilify, which makes use of its Captisol solubility technology has
been launched in the USA.
US-based CyDex's Captisol technology has now been FDA approved and commercialised for three different products in the US: Pfizer's antifungal Vfend (voriconazole) and schizophrenia treatment Geodon (ziprasidone) and Bristol-Myers Squibb's Abilify (aripiprazole).
The injectable version of Abilify uses the Captisol technology to improve the stability and solubility of the active pharmaceutical ingredient. CyDex says it is seeing increasing demand for the technology because the frequency of unstable and insoluble molecules in drug development pipelines is on the rise.
In total, CyDex has over twenty licenses with pharmaceutical and biotechnology companies for the use of Captisol technology in their development and clinical programmes.
Aside from the benefits in the bioavailability of Captisol-formulated drugs, CyDex also said the use of the technology means partners end up with extended intellectual property rights for their franchises.
"Captisol is an important component of CyDex's drug delivery technology business. However, an increasing portion of our revenues is coming by way of licensing proprietary drug products developed by CyDex scientists, which are licensed out to partners who conduct late phase clinical trials and subsequently commercialize those products," Jose Rodriguez, CyDex' vice president - business development, told In-PharmaTechnologist.com.
"We are very excited about the future of Captisol and the next generation substituted cyclodextrin technology which we are currently working on, and which we hope to make available to partners in the next 1-2 years."
The technology works by forming complexes with water-insoluble drugs, making them water-soluble. When given by injection, a Captisol-enabled formulation helps carry a drug into the patient's bloodstream, where the excipient and the drug dissociate, allowing the active ingredient to produce its desired pharmacological effect rapidly.
The Abilify injection offers healthcare workers the first ready-to-use single-dose vial to calm the patient.
"Acute agitation can be very serious, distressing and potentially dangerous for patients, healthcare professionals and caregivers," said Michael Allen, of University of Colorado at Denver and Health Sciences Center's School of Medicine.
"Abilify injection controls agitation independent of sedation."
Abilify has become a vital drug for B-MS of late and sales for the third quarter reached $233 million, a 20% rise on the previous year. The company has been rolling out new formulations of the drug to extend the franchise since its launch in 2002, introducing low-dose tablet and oral liquid versions earlier this year. Abilify is partnered with Otsuka of Japan.
