Drugs in Trials for Growing PTSD Market

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Post-traumatic stress disorder (PTSD) is a psychological condition that develops after a person is exposed to any traumatic event and, unfortunately, it is predicted to be a growth market. Several companies are developing new drugs to meet the need.

PTSD is a relatively new name for an old condition. Over the course of its history it has been called by other names, including soldier’s heart, shell shock and traumatic neurosis. PTSD is classified as an anxiety disorders, its symptoms can develop immediately after a traumatic event or during the course of time. Its symptoms normally include re-experience of the traumatic event, avoidance of the incidents, and abnormal mood swings. It can occur in individuals of any age, irrespective of the gender. PTSD is also often associated with substance abuse and unpredictable or violent behaviors, making it an important public health concern.

Current treatments for PTSD include psychological counseling, which help in identifying the cause of the condition and providing counseling to come out of the situation. Medications present in the market help in reducing the symptoms during the course of the treatment. Drugs prescribed along with the treatment include Zoloft (sertraline HCl) by Pfizer, Paxil (paroxetine) by GlaxoSmithKline, Elavil (amitriptyline) by AstraZeneca. Other off-label drugs include Risperdal(risperidone), Zyprexa (olanzapine), and Seroquel (quetiapine).

PTSD a Growing Market

It is estimated that approximately 8 million Americans, or 3.5% of the US population, suffer PTSD at any given time. Similarly, an estimated 1 million Australians experience PTSD in any year, and 12% of Australians will experience PTSD during their lifetime. The anxiety and depression treatments markets are projected to reach US$18.2 billion by 2020.

Rising incidences of personal violence and road accidents in developing countries is one of the driving forces for the market, but due to lower awareness and underdeveloped medical sector, the market growth is lower. Market opportunities also lie in the rehabilitation of injured military personnel where majority of the traumatic patients complain symptoms for intrusive memories and emotional arousal. According to an article published in Australia and New Zealand Journal of Psychiatry, 2010, around 17% of Iraq war veterans suffered with PTSD. Similar statistics suggest a large number of was veterans suffer from PTSD, but do not receive medical treatment.

The market growth has suffered from the serious side effects of drugs leading to several lawsuits and bad publicity. Serious side effects for Zoloft and Paxil in pregnant women were miscarriage, septal heart defects, cranial defect, delayed development and Persistent Pulmonary Hypertension (PPHN). An article published in The New York Times in 2012, GSK agreed to pay fine of USD 3 million for promoting its antidepressants which include Paxil, Wellbutrin, and Avandia.

New PTSD Drugs in Development

Australian drug development company Bionomics Limited is launching a key Phase 2 trial of its novel anxiety drug BNC210 as a treatment for PTSD, following a US $12 million private placement to US institutional investors.

According to their research, the risk of developing PTSD after a traumatic event is 8.1% for men and 20.4% for women. Bionomics’ study will recruit male and female subjects and will aim to demonstrate improvement in PTSD symptoms following 12 weeks of daily dosing with BNC210. Further study details will be provided on trial initiation.

The new trial is expected to begin in the first half of 2016, with patients to be recruited at several trial sites in Australia and New Zealand. All patients enrolled will have experienced severe trauma, including war, natural disasters or have been involved in serious accidents.

Bionomics CEO and Managing Director Dr Deborah Rathjen said all existing data indicated that BNC210, which is currently in trial to treat Generalised Anxiety Disorder, could be an effective therapy for PTSD patients.The company has previously reported clinical and preclinical data indicating that BNC210 is safe and well-tolerated and has strong potential as a new and effective treatment for other central nervous system indications.

Tonix, based in New York, is also developing a PTSD drug. TNX-102 SL (cyclobenzaprine HCl sublingual tablet) is a potential first-in-class drug that acts upon multiple neurotransmitter systems believed to regulate sleep quality. It offers the promise to provide benefit in PTSD, including relief from sleep disturbances and nightmares without common side effects associated with the approved class of drugs (SSRI) to treat this condition.

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