The US Food and Drug Administration (FDA) has asked Amylin Pharmaceuticals for more data on the prefilled pen device it wants to use to deliver Bydureon (exenatide). Amylin won FDA approval for a syringe-version of Bydureon in January but wants to offer a more convenient device for patients.
In a US Securities and Exchange Commission (SEC) filing Amylin said it will respond to the FDA “in a timely fashion” and is aiming to have the pen delivery device on the market in the next calendar year.
Drug delivery CRO (contract research organisation) Particle Sciences has added coating capabilities for preparing polymer film-based drugs from liquid formulations. Particles Sciences has added the semi-automated coating equipment to meet a shift in demand from its clients.
Garry Gwozdz, director, formulation services at Particle Sciences, said: “Increasingly, we are seeing a demand for thin film-based products, particularly with respect to transdermal drug-eluting patch products, and rapidly-dissolving strips.”
Transdermal Specialties Inc is introducing an insulin patch at the American Diabetes Association’s annual meeting this weekend. The U-Strip technology uses an alternating ultrasonic waveform to make skin pores bigger to allow large molecules to pass through the skin and into the dermis.
Bruce Redding Jr, CEO of Transdermal Specialties, said: “We believe the technology has the potential to increase the number of pharmaceuticals which may be delivered transdermally from a number less than 20 currently expanding past the 175 formulations already modelled by Transdermal Specialties.”
Zogenix has submitted an investigational new drug (IND) application to the FDA for a combination of its needle-free drug delivery device with a once-monthly formulation of schizophrenia-treatment risperidone.
Roger Hawley, CEO of Zogenix, said: “We are encouraged by Relday's potential of improving patient compliance due to the safety and convenience provided by DosePro's needle-free delivery system combined with a long-acting formulation of an established antipsychotic.”
pSivida has received a US patent for an inserter used in administration of its micro-drug delivery devices. The drug delivery firm plans to use the tool in Phase III trials of its posterior uveitis insert.
"We have designed it to allow the insertion of drug delivery devices, such as our Medidur implant, through a far smaller needle than was previously possible and to require significantly less force to administer”, Paul Ashton, president and CEO of pSivida, said.