Tiny needle pills for painless injections passes first human trial

A pill that could replace conventional injections has passed its first tests in people with flying colours, according to the company developing it.

“It’s completely pain-free,” says Mir Imran, the head of Rani Therapeutics of San Jose, California. “Not a single subject felt anything.”

He says the results provide hope for millions of people – such as those with diabetes – who want an alternative to painful injections. It is estimated that one in 10 people have a fear of needles.

The RaniPill, as it is called, looks like a larger version of a normal pill. When swallowed, it passes through the stomach untouched. The outer covering only dissolves in the less acidic environment of the intestine.

When this happens, a tiny balloon inflates and pushes a small needle into the muscular wall of the intestine that injects the drug the pill is carrying. The balloon then deflates and the remains of the pill are excreted. The intestine has no receptors for sharp pain and heals very quickly.

In a trial in Australia, 52 people were given RaniPills containing octreotide, a drug used to treat certain cancers and growth disorders. They felt no pain or discomfort, and the pill was as effective at delivering the drug as conventional injections.

At present, octreotide is given as a large injection into the buttocks once a month. “Patients describe it as amazingly painful,” Imran says.

Many drugs, such as insulin, are destroyed in the gut if swallowed, so they have to be injected directly. But people who hate needles often delay or skip injections, and can develop serious complications as a result. Having a painless alternative to injections should reduce the risk of this as well as making people’s lives more pleasant.

Rani Therapeutics is in discussion with large pharmaceutical companies and regulators in the US and the EU, Imran says, and the company plans further trials this year. It is focusing on using the device to deliver nine drugs initially, including octreotide and insulin.

“The development of oral insulin would be a breakthrough in making diabetes easier to manage on a daily basis,” says Edward Johnston at Diabetes UK.

However, he points out that the full results of the RaniPill trial have yet to be published. “It’s important to also note that this system would need extensive trials in people with diabetes to truly understand its viability as a replacement for insulin injections,” says Johnston.

Other groups are also working on similar systems. A team at MIT has developed a pill designed to inject drugs into the lining of the stomach, rather than the intestine, but it has been tested only in animals so far.