Opioid Pain Drug by Pfizer and Acura approved by FDA

The FDA has granted approval for an abuse-resistant opioid formulation made by Acura Pharmaceuticals (NASDAQ:ACUR) and Pfizer (NYSE:PFE).  The drug is a reformulation of immediate release oxycodone.  The trade name of the drug will be OXECTA, it was previously known as ACUROX.  Pfizer’s media relations said that they can provide more information once the press […]

Neurogesx and Depomed seek to persuade pain specialists

I attended a recent medical conference where pain specialists outlined the history and direction of the pain industry, covering both nociceptive and neuropathic pain.   After the conference, I had a chance to talk one-on-one with several pain specialists.  I asked for their input on the industry and several products that I found particularly promising. […]

Pfizer moves forward with Pristiq for Hot Flashes

Last week, Pfizer (NYSE:PFE) announced that they had presented results from sub-study of Pristiq (desvenlafaxine) at the 59th annual clinical meeting of the American College of Obstetricians and Gynecologists (ACOG). The results were from a large, phase 3 trial, that sought to elaborate the safety and efficacy of Pristiq for the use in hot flashes […]

Xenoport Drug Horizant approved

Today, the FDA approved Xenoport’s (NASDAQ:XNPT) and GlaxoSmithKline’s (NYSE:GSK) Horizant (gabapentin enacarbil) for the treatment of Restless Leg Syndrome (‘RLS’). EfficacyThe efficacy of Horizant in the treatment of patients with moderate-to-severe primary RLS was demonstrated in two 12-week clinical trials in adults. Recommended DoseThe recommended dosage of Horizant  is 600 mg once daily taken with food at about […]

Strategies and Outlook for Xenoport’s Upcoming FDA PDUFA Date

Within a week, Xenoport (NASDAQ:XNPT) and partner GlaxoSmithKline (NYSE:GSK) should receive feedback from the FDA regarding the NDA for Horizant, a gabapentin pro-drug for the treatment of Restless Leg Syndrome (‘RLS’). With several recent clinical trial failures, approval is paramount for Xenoport. Earlier this month, Xenoport announced that its ‘GERD’ product candidate, arbaclofen placarbil, was […]

Despite Abbott Parting With Gralise, Depomed’s Future Looks Bright

During the past week, Depomed (DEPO) announced two significant business development updates. On March 15th, Depomed granted non-exclusive rights for its proprietary extended-release metformin patents, this time, to Boehringer Ingelheim. On March 16th, Depomed announced that they and Abbott (ABT) have reached an agreement over Gralise. Moving Forward From Abbott The details of the agreement […]

Bionovo Completes Financing, Announces Plan of Action: Is the Worst Over?

Earlier this month, Bionovo (NASDAQ:BNVI), a development-stage pharmaceutical company, announced a plan of action for its lead product candidate, Menerba, an oral, botanical, drug candidate for the treatment of menopausal hot flashes. In the press release, the company clearly communicated its goal with regards to Menerba’s development timeline (click to enlarge images): This new timeline is […]

FDA Setbacks Make Vivus a Buying Opportunity

Vivus (NASDAQ:VVUS), a specialty pharmaceutical company, has faced some setbacks with its drug candidate, Qnexa, an investigational treatment for obesity, obstructive sleep apnea and diabetes. In October 2010, Vivus received a Complete Response Letter from the FDA, outlining a path to approval, which left investors who expected approval dissappointed. In January 2011, the company met […]

Depomed: Attractive and Under-Appreciated Potential

It almost seems counterintuitive that majority shareholders of Depomed (DEPO) have been adding shares after the FDA approval of Gralise, a once-daily treatment for post-herpetic neuralgia. One might expect that large funds would look to the high volume created with an FDA decision as an opportune exit strategy. Yet that hasn’t happened, several funds have […]

Sales Potential and Chances of FDA Approval for DepoMed’s DM-1796

Many biotech investors have been closely watching the upcoming PDUFA date for DM-1796, DepoMed’s (DEPO) investigational extended-release gabapentin formulation. Depomed’s story has been marred with ups and downs, panicking those investors with a faint heart and forcing weak hands to exit, while the major funds continue to accumulate shares. To understand DM-1796’s approvability and its […]

Finding Opportunity in Abbott – Depomed Dispute

Tuesday, Depomed (DEPO) announced that Abbott (ABT) is disputing elements of their contract regarding DM-1796, an investigational extended-release gabapentin formulation. According to the conference call and press release, CEO Carl Pelzel is “perplexed” by Abbott’s last minute maneuvers and expressed haste in beginning the mediation process and, if needed, binding arbitration. Issues with the contract The issues are […]

Investment Opportunities in Women’s Health

The next several months will be an exciting time for the women’s health space, with several important events that may represent an opportunity for investors. Most notably, Pfizer (PFE) has completed data collection for it’s 2186-patient study of Pristiq for the treatment of vasomotor symptoms, more commonly known as hot flashes. Wyeth, now part of […]