could something old be new again?

Which will be the third opioid to be added to POH’S pain portfolio?

Prior to evaluating transdermal delivery of oxycodone, Phosphagenics ran a series of trials in 2006 to assess the transdermal delivery of morphine via gel and cream. Results were successful and in early 2007 the company indicated its intention to move to patch delivery of morphine. Meanwhile, testing had also begun with oxycodone, but in late 2007 Harry Rosen announced that the company, after commercial discussions, had decided to prioritise oxycodone over morphine. TPM morphine was put on ice.

I’m now wondering if transdermal morphine isn’t about to be revived.

Morphine has been around for a long time (it was introduced into the United States almost 200 years ago) but retains its place as the best known and most commonly prescribed opioid especially in the management of cancer pain. Although there are many different opioids, few are currently available in approved extended release formulations. Morphine is one of these. Four major brands of extended release morphine are Kadian (Actavis), MS-Contin (Purdue), Avinza (Pfizer, ex-King) and Embeda (morphine in combination with naltrexone, Pfizer, ex-King).

Pfizer's Embeda was recalled with “stability” issues in 2011 and is still off the market. Prior to recall, sales were approximately $70 million pa. Patent expiry is not until 2027.

Avinza is a once-daily modified release morphine tablet. Sales seem to have peaked at $95 million pa in 2010. Patent expiry will be in November 2017.

Purdue’s MS-Contin is no longer subject to patents and there are now many generic forms. There is a suggestion that sales of MS-Contin and its generics were valued at $173 million in 2011.

Kadian, which is marketed by Actavis, came off patent in late 2011. Watson has sold a generic version since early last year. Kadian sales in 2010 were reported at $275 million.

There are a number of reasons why morphine might just be selected as POH’s third transdermal opioid.

(1) Initial testing has already been successfully completed by POH.

(2) Morphine is an opioid therapy long proven as effective in the treatment of severe pain. As a standard therapy within any physician’s chronic pain armamentarium, it would seem to be a logical addition to an opioid portfolio.

(3) There appears to be a substantial established market in oral extended release morphine products (>$500 million). All come with GI side effects, none lasts longer than a day and none is ideal in cases of dysphagia caused by either cancer or its treatment.

(4) There is currently no transdermal morphine product on the market.

(5) Two well-known brands of extended release morphine are off patent.


Could something old be new again?