Spray-on contraceptives to penetrate $6.7bn market

Biopharmaceutical firm Organon has licensed the spray technology from Australian transdermal drug delivery biotech Acrux.

Using this transdermal delivery technique, the companies hope to avoid the potential impact of vomiting, diarrhoea, fluctuating absorption or first-pass metabolism breaking compounds down into other active materials that is a risk with oral contraceptive products.

If successful, the companies hope to take a sizeable chunk of the $6.7bn (€5.1bn) contraceptive market.

The novel drug delivery method uses a hand-held applicator to deliver a fast-drying formulation to the skin, consisting of an alcohol-based carrier with the active ingredient, along with a skin penetration enhancer.

The volatile component evaporates quickly leaving the spray dry on the skin within a minute, with the contraceptive component and skin penetration enhancer being absorbed and forming a depot within the outer layer of the skin.

The contraceptive then diffuses into the bloodstream over a period of 24 hours.

Daily application of the spray tops up the depot so that a steady level of contraceptive is released into the blood.

The treatment will work in similar fashion to traditional contraceptive pill products, in that it will take an initial period of daily administration before contraceptive protection is ensured.

As the compound is absorbed into the outer layer of the skin within a minute, the company claim that clothing brushing against the skin poses little risk of the compound being removed and contraceptive protection being lost.

However, Acrux has carried out clinical studies to determine the effect of washing or rubbing after application, and data from previous products suggests that swimming or showering should be possible within 30 minutes of application with no impact on the treatment's efficacy.

The spray itself can be applied anywhere on the skin, but in the past the inner arm has been the area of choice.

"The spray is a convenient, discreet method," Dr Richard Treagus, Acrux CEO told In-PharmaTechnologist.com.

"It is fast-drying, invisible and doesn't irritate the skin.

The hormones are going straight into the bloodstream, avoiding the digestive system."

Each applicator is typically supplied with a month's supply of drug, though it will be up to Organon to decide whether to opt for disposable applicators to be replaced each month, or reusable applicators with individual cartridges.

There are also a series of features which Organon could choose to incorporate into the applicator, Dr Treagus explained.

Child-proofing, lock-outs and dose-counting and recording are all functions that are available for addition to the basic applicator product.

The cost of the spray-on contraceptive is likely to be similar to existing contraceptive pills on the market, and the companies foresee a two-year shelf life for the product.

Under the licensing deal between the two companies, Acrux will be responsible to developing formulations of selected contraceptive compounds and Organon will undertake and fund clinical trials, regulatory submissions, manufacturing and marketing.

For each compound Organon elects to develop, Acrux will receive between $12m and $16m in development and regulatory milestone payments, as well as royalties on worldwide sales of each product.

"Oraganon operates globally, but we expect the USA and key European markets to be prime targets," said Treagus.

"A contraceptive patch approved only in the USA sells more than $400m per annum.

We believe this is an indication of the potential for a range of superior transdermal products with different contraceptive combinations."

Acrux already has a nestorone (progesterone)-based contraceptive spray product in development independently, which successfully completed Phase I studies last year.

Organon has already selected its first contraceptive compound to develop as a spray, with work on the product starting immediately.

It is anticipated that these first contraceptive sprays could enter the market within four to five years, though Organon's products could beat Acrux's nestorone spray to the shelves despite the headstart in development, according to Treagus.

Acrux is hoping to expand the collaboration with Organon further, which suggests the possibility of the spray technology being applied in Organon's other key therapeutic areas of fertility, gynaecology and anaesthesia.