Pharma Tech Industries (PTI), the largest pharmaceutical contract manufacturer and packager of powder products in the world, has been selected to handle filling, assembly, and packaging services for a migraine relief medication administered through an innovative new method: a breath-powered nasal delivery system. The drug itself is powder-based, and PTI was chosen for this initiative – which will start as developmental, supporting FDA submission for approval and will continue into commercial – due to the company’s experience handling a broad range of powders, and its ability to vertically integrate the entire production process.
The OptiNose delivery system employs a novel means of easily administering drugs deep into the nasal cavity, enabling the treatment of both local and systemic diseases. The new technology offers a much-needed alternative to existing, poor-performing nasal sprays, as well as to tablets and injections. OptiNose has completed Phase III development for a Sumatriptan Succinate medicine that, when taken using its patented device, is expected to shorten the timeframe for relief from migraines when compared to widely used oral migraine medications.
Pharma Tech Industries will play a critical, turn-key role in preparing OptiNose’s NDA batches over the coming months. Utilizing a Planeta capsule filler from leading equipment manufacturer MG2, PTI will fill low-dose capsules with dry powder medication, achieving tight weight tolerances at high commercial speeds. From there, the capsules will be loaded into special unit-dose cartridges. PTI will then pack each cartridge – along with the primary nosepiece and an instruction insert for the end-user – into individual cartons, where they are mechanically packed into cases and palletized for shipping.
“We chose Pharma Tech Industries as our CMO through a rigorous selection process that evaluated more than half a dozen potential candidates,” said Peter Miller, CEO of OptiNose. “We are working to bring a groundbreaking delivery system to market, and its commercial development depends upon a partner that can execute with excellence. We believe that Pharma Tech Industries is such a partner.”
“It is exciting to work so closely with the team at OptiNose, who have spearheaded the creation of a very promising new drug delivery system, and we are thankful for this opportunity,” said Tee Noland, chairman of Pharma Tech Industries. “This project allows PTI to showcase the broad spectrum of capabilities that make us such an attractive option for our customers.”
Intranasal formulations of some triptans – including sumatriptan and zolmitriptan – were developed with the intent of achieving faster onset of action compared to tablets, and a more appealing delivery method than injections. Many patients have nausea and, even without nausea, gastric emptying is often delayed during migraine attacks. This is a key reason tablets may not be as fast and effective as other delivery methods.
Current nasal sprays deliver much of the dose to the anterior third of the nose in front of the nasal valve, where absorption is inefficient and where part of the dose is easily lost to “drip out.” The remainder passes along the floor of the nose to be swallowed, where it offers no advantage over standard oral delivery.
The OptiNose breath-powered, bi-directional delivery device simply and reliably delivers medication deep into the nasal cavity, while preventing initial deposition in the mouth and lungs. This has potential to greatly increase the efficiency of nasal absorption of medication while reducing the amount of drug that is swallowed. This new form of drug delivery means that even with a much lower dose, the new migraine product has potential to produce fast and effective pain relief.
In a recently completed phase III trial, OptiNose technology was used to deliver 16mg of Sumatriptan. The study demonstrated that OptiNose Sumatriptan provided fast and statistically significant headache relief.